In April 2026, Arrow International initiated an urgent medical device recall for multiple hemodialysis catheter kits containing the Merit Medical 16F Dual-Valved SplittAble Sheath Introducer due to a design defect that may prevent the sheath from splitting as intended. Affected products include the Arrow Edge, Arrow-Clark VectorFlow Antegrade, Arrow-Clark VectorFlow Retrograde, Cannon II Plus, NextStep Antegrade, and NextStep Retrograde hemodialysis catheter lines. The FDA issued an Early Alert recommending immediate cessation of use and return of affected kits. In January 2026, parent company Teleflex underwent a leadership transition with interim CEO Stuart Randle assuming office to oversee a strategic restructuring focused on high-acuity vascular and surgical segments. Teleflex reported 2025 GAAP continuing operations revenue of $1.99 billion (+17.2% year-over-year), with the Vascular segment delivering pro forma adjusted constant currency growth of 2.4% in the second half of 2025. Teleflex scheduled its 2026 annual shareholder meeting for May 15, 2026 at company headquarters in Wayne, Pennsylvania.
Company Profile (Updated April 2026)
Arrow International, Inc. is a premier American medical device manufacturer focused on the design, production, and commercialization of disposable vascular access devices, catheters, and procedure kits for critical care, emergency medicine, interventional cardiology, and dialysis applications. Headquartered in ReADINg, Pennsylvania, USA, the company was founded on December 8, 1975, when a group of local investors purchased the Arrow Products Division from Rockwell International. Over five decades, Arrow has established itself as one of the most trusted and innovative brands in vascular access, with its products used in hospitals, trauma centers, and clinics across more than 150 countries.
Development History:
- 1975: Arrow International, Inc. founded in Reading, Pennsylvania, as a privately owned company spun out from Rockwell International's Arrow Products Division
- 1977: Introduced the Internal Jugular Puncture Kit, becoming the first company to offer sterile catheter kits with matched components for specific procedures utilizing the Seldinger Spring-wire guide technique
- 1978: Developed the first polyurethane catheter in response to physician demand for a softer indwelling material; polyurethane remains the industry's most popular CVC material today
- 1992: Launched Arrowg+ard Blue Technology, the first catheter with broad-spectrum antimicrobial protection combining chlorhexidine and silver sulfadiazine, later validated by 30+ studies to reduce catheter-related bloodstream infections (CRBSI)
- 1998: Introduced the first Arrow PICC (peripherally inserted central catheter) featuring staggered exit sites and the BlueFlexTip design
- 2000: Arrowg+ard Blue Plus received FDA clearance, adding intra-luminal antimicrobial protection to the existing extra-luminal chlorhexidine/silver sulfadiazine coating
- 2007: Teleflex Incorporated acquired Arrow International (October 2007); the Arrow brand became the cornerstone of Teleflex's Vascular Access division
- 2007: Teleflex introduced the first pressure injectable Arrow CVC, enabling contrast injection for medical imaging without catheter replacement
- 2010: Launched the Arrowg+ard Blue Advance PICC, the first broad-spectrum antimicrobial PICC with both intra- and extraluminal chlorhexidine protection; FDA-cleared for antithrombogenic protection in 2012
- 2014: Teleflex acquired Vidacare, integrating the EZ-IO Intraosseous Vascular Access System into the Arrow brand portfolio for emergency and critical care bone marrow access
- 2020: Teleflex acquired Z-Medica, adding QuikClot hemostatic products to strengthen emergency medicine and critical care offerings
- 2022: Launched the Arrow Pressure Injectable Midline Catheter portfolio with bright yellow hubs and labeling to reduce line identification confusion and improve patient safety
- 2025: Teleflex reported $1.99 billion in GAAP continuing operations revenue, with Arrow-branded vascular access products contributing significantly to the Vascular segment
- 2026: Teleflex initiated strategic restructuring to focus on high-acuity vascular and surgical segments; Arrow recalled select hemodialysis catheter kits in April due to a third-party sheath component issue; Teleflex Interventional showcased coronary and peripheral vascular technologies at CRT 2026 (March 7–10, Washington, DC, Booth #414)
Core Mission: To improve the health and quality of people's lives by providing purpose-driven, innovative vascular access solutions that minimize infection risk, enhance procedural efficiency, and enable clinicians to deliver safer, more effective patient care across critical care, emergency medicine, interventional procedures, and chronic dialysis.
Product Portfolio & Technology Platform
Central Venous Catheters (CVC)
Arrowg+ard Blue Advance CVC:
- Next-generation antimicrobial central venous catheter with both intra- and extraluminal chlorhexidine protection
- Provides broad-spectrum antimicrobial coverage against gram-positive bacteria, gram-negative bacteria, and fungi
- Available in single, double, triple, and quadruple lumen configurations
- Pressure injectable options for contrast-enhanced imaging procedures
- Proven to reduce central line-associated bloodstream infections (CLABSI) and associated healthcare costs
Peripherally Inserted Central Catheters (PICC)
Arrow Pressure Injectable PICC:
- Available with Arrowg+ard Blue Advance antimicrobial and antithrombogenic protection
- Pre-loaded with Arrow VPS (Vascular Positioning System) Stylet or TipTracker Stylet for accurate tip placement
- Pressure injectable up to 5 mL/second for diagnostic imaging and Rapid fluid administration
- BlueFlexTip design for vessel preservation and reduced thrombosis risk
Midline Catheters
Arrow Pressure Injectable Midline:
- Bright yellow colored hubs, pinch clamps, and labeling to prevent catheter identification confusion with PICCs and CVCs
- TAPERFREE design ensuring consistent French size from distal tip to hub, aligned with INS 45% catheter-to-vein ratio recommendations
- Pressure injectable up to 5 mL/second through either lumen
- Available in 1-lumen and 2-lumen configurations with ergonomic trimmer featuring a visualization window
Intraosseous Vascular Access (EZ-IO)
Arrow EZ-IO System:
- The only IO system FDA cleared for up to 48-hour dwell time
- Color-coded needle set system (15mm, 25mm, 45mm) for quick selection and post-insertion identification
- Diamond needle tip designed for precision performance in adult and pediatric patients
- Battery-powered driver and manual insertion options; single-use power driver available
- Complete procedure tray including EZ-Stabilizer dressing, EZ-Connect extension set, ChloraPrep antiseptic, and sharps disposal cup
Hemodialysis Catheters
Arrow Chronic & Acute Hemodialysis Catheters:
- Arrow Edge Hemodialysis Catheterization Product: Designed for acute and chronic dialysis access
- Arrow-Clark VectorFlow Antegrade: Available for optimized blood flow
- Arrow-Clark VectorFlow Retrograde: Retrograde configuration for chronic hemodialysis
- Cannon II Plus Chronic Hemodialysis Catheter: Long-term dialysis access solution
- NextStep Antegrade: Step-tip design for chronic hemodialysis
- NextStep Retrograde: Retrograde step-tip design for chronic hemodialysis
- Recall Notice (April 2026): Arrow recalled dialysis catheter kits containing the Merit Medical 16F Dual-Valved Splittable Sheath Introducer due to potential failure to split, which may result in hemorrhage, foreign body retention, or impaired catheter function. Affected customers were notified by letter in April and advised to immediately stop using or distributing impacted kits and return them to Arrow International. Consumers may contact Teleflex customer service at Recalls@teleflex.com or by calling 1-866-396-2111.
Arterial Access & Hemodynamic Monitoring
Arrow Arterial Catheter Systems:
- Standard Seldinger Technique and Integrated Seldinger Technique options
- QuickFlash System combining peripheral IV ease with integrated Seldinger advantages
- Hydrophilic-coated polyurethane construction for reliable waveform transmission
- Flexible suture wings and low-profile designs for secure fixation
ErgoPack Complete Systems
Arrow ErgoPack Complete Portfolio:
- Ergonomic top-down, left-to-right tray configuration for procedural efficiency
- Available for CVC, multilumen access catheter (MAC), and percutaneous sheath introducer (PSI) systems
- Includes Arrow GlideWheel Advancer, kink-resistant nitinol guidewire, transducer cover, prefilled saline syringes, and dual ChloraPrep skin preparation
- Arrowg+ard Blue MAC and PSI catheters with full-spectrum antimicrobial protection
Hemostasis & Emergency Medicine
QuikClot Hemostatic Products:
- Acquired through Z-Medica (2020) to strengthen emergency medicine portfolio
- Advanced hemostatic gauze and dressing solutions for trauma and surgical bleeding control
Regulatory Status & Quality Standards
FDA & International Certifications
- U.S. FDA Registration: Arrow International operates as a registered FDA medical device establishment under Teleflex Incorporated
- CE Marking: Arrow vascular access products hold CE Mark approval for distribution in the European Union and EMEA markets
- ISO 13485: Manufacturing quality management system compliance through Teleflex
- Australian TGA & New Zealand MedSafe: Arrow Pressure Injectable Midline approved for distribution
Recent Regulatory Actions
- April 2026 Recall: Urgent medical device recall of Arrow hemodialysis catheter kits containing the Merit Medical 16F Dual-Valved Splittable Sheath Introducer; FDA issued an Early Alert recommending immediate cessation of use and return of affected kits
- November 2023 Recall: Class I recall of Arrow and Teleflex Pressure Injectable Catheter Kits due to mislabeling of chlorhexidine coating status on kit lids; 1,905 devices recalled in the U.S.
Financial Performance (Within Teleflex Group)
Teleflex Continuing Operations (FY2025)
- GAAP Revenue (Continuing Operations): $1,992.7 million (+17.2% vs. prior year)
- Adjusted Revenue (Continuing Operations): $1,983.7 million
- Vascular Segment Growth (2H 2025): +2.4% pro forma adjusted constant currency
- Interventional Segment Growth (2H 2025): +8.1% pro forma adjusted constant currency
- Surgical Segment Growth (2H 2025): +3.2% pro forma adjusted constant currency
- Total Cash & Equivalents: $402.7 million as of December 31, 2025
2026 Outlook (Teleflex Guidance)
- GAAP Revenue Growth (Continuing Operations): 14.4% to 15.4%, including approximately 0.7% positive FX impact
- Pro Forma Adjusted Constant Currency Growth: 4.5% to 5.5%
- Expected GAAP Revenue Range: $2.28 billion to $2.30 billion
- Adjusted EPS Guidance: $6.25 to $6.55
- Strategic Restructuring: Teleflex divested urology and OEM businesses to focus on high-acuity vascular and surgical segments; $1 billion share buyback and $800 million debt paydown planned
Company Overview
Corporate Information
Company Name: Arrow International, Inc.
Founded: December 8, 1975
Headquarters: 2400 Bernville Road, Reading, Pennsylvania 19605, USA
Phone: +1 (610) 378-0131
Parent Company: Teleflex Incorporated (NYSE: TFX, 100% ownership since October 2007)
Company Type: Wholly Owned Subsidiary
Industry: Medical Devices / Vascular Access / Critical Care
Employees: Approximately 4,000 (as part of Teleflex global workforce)
Teleflex Leadership (2026)
Interim Chief Executive Officer: Stuart Randle
- Assumed interim CEO role in January 2026 following departure of former CEO Liam Kelly; veteran of the MedTech industry with expertise in corporate turnarounds
Former CEO: Liam Kelly (served 2018–January 2026)
- Departed following activist shareholder pressure related to share price performance and NeoTract acquisition underperformance
Board Chair: Steven Gunby
Key Arrow Brand Executives (Historical & Current)
- Lisa Kudlacz: Former President and General Manager, Vascular Access Division, Teleflex (oversaw Arrow midline catheter launch)
- Matthew James: President, EMEA, Teleflex (led Arrow EMEA expansion)
Global Market & Competitive Landscape
Target Markets
United States: Core market with deep penetration in academic medical centers, teACHing hospitals, trauma centers, and dialysis clinics; direct sales force and distributor networks
Europe, Middle East & Africa (EMEA): Strong presence through Teleflex EMEA infrastructure; Arrow Pressure Injectable Midline and CVC portfolios actively marketed
Asia-Pacific: Distribution in Australia, New Zealand, Southeast Asia, and India through regional distributors and Teleflex subsidiaries
Americas: Canadian and Latin American markets served through Teleflex regional operations
Primary Competitors
- Becton Dickinson (BD): Global leader in vascular access with MaxZero, Nexiva, and PICC product lines
- B. Braun: German competitor in CVC, PICC, and dialysis catheter markets
- Medtronic: Vascular access and interventional products
- Cook Medical: Specialized in minimally invasive vascular devices
- Merit Medical: Dialysis access, drainage, and interventional products (supplier of recalled sheath component in 2026)
- AngioDynamics: Vascular access, oncology, and peripheral intervention
- Smiths Medical: Port-a-Cath and vascular access solutions
Competitive Advantages
- 50-Year Innovation Heritage: Pioneer of polyurethane catheters, Seldinger technique kits, and antimicrobial catheter technology with unmatched clinical validation
- Arrowg+ard Technology Leadership: 30+ peer-reviewed studies validating CRBSI reduction; only chlorhexidine-based antimicrobial platform with both intra- and extraluminal protection
- Comprehensive Portfolio Breadth: Full-spectrum vascular access from peripheral midlines to central lines, intraosseous emergency access, and chronic dialysis—rare in the industry
- EZ-IO Market Dominance: Only FDA-cleared intraosseous system for 48-hour dwell; standard of care in emergency medicine and military trauma
- Teleflex Global Scale: Access to Teleflex's $2+ billion revenue base, 80-country distribution network, and shared R&D infrastructure
- Procedural Efficiency Focus: ErgoPack Complete systems designed to reduce CLABSI risk and improve compliance with CDC, INS, and SHEA guidelines
Clinical Evidence & Key Studies
Arrowg+ard Clinical Validation
- 30+ Published Studies: Arrowg+ard Blue, Blue Plus, and Blue Advance technologies have been evaluated in independent clinical trials and health economic analyses demonstrating significant reductions in CRBSI rates compared to uncoated catheters
- Antimicrobial Spectrum: Effective against gram-positive bacteria, gram-negative bacteria, and fungi—the primary pathogens responsible for healthcare-associated infections
- Antithrombogenic Protection: Arrowg+ard Blue Advance PICC FDA-cleared (2012) to help protect against vessel thrombosis, fibrin sheath formation, and catheter occlusion
2026 Outlook & Strategic Priorities
Near-Term Objectives
- Regulatory Resolution: Complete FDA recall remediation for hemodialysis catheter kits and restore full product availability
- Teleflex Restructuring Alignment: Support parent company's strategic pivot toward high-acuity vascular and surgical segments following divestiture of urology and OEM businesses
- Vascular Segment Growth: Drive 4.5–5.5% pro forma adjusted constant currency revenue growth in 2026 through Arrow-branded antimicrobial catheter adoption and international expansion
- Innovation Pipeline: Continue development of next-generation pressure injectable catheters, advanced antimicrobial coatings, and integrated procedural tray systems
- Global Distribution Expansion: Leverage Teleflex's 80-country network to increase Arrow product penetration in Asia-Pacific and emerging markets
- Annual Shareholder Meeting: Teleflex will hold its 2026 annual meeting of shareholders on May 15, 2026 at company headquarters in Wayne, Pennsylvania
Contact Information
Corporate Headquarters
Address: 2400 Bernville Road, Reading, Pennsylvania 19605, USA
Phone: +1 (610) 378-0131
Parent Company
Teleflex Incorporated
Address: 550 E. Swedesford Road, Suite 400, Wayne, Pennsylvania 19087, USA
Phone: +1 (610) 948-2700
Stock Exchange: New York Stock Exchange (Ticker: TFX)
Website: www.teleflex.com
Customer Service & Recall Support
Email: Recalls@teleflex.com
Phone: 1-866-396-2111 (U.S. toll-free)
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