ARROW IPN036962Recalls & reported problems
Teleflex Incorporated · Arrowg+ard Blue(R) Two-Lumen Hemodialysis Catheterization for High Volume Infusions · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 50801902123157), received between Jan 31, 2024 and Aug 15, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Frayed” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Frayed1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2025Material Frayed; Material Frayed
IT WAS REPORTED "THE WIRE FRAYED UPON INSERTION". A NEW KIT WAS OPENED AND THE LINE WAS PLACED SUCCESSFULLY. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".
Patient problems: Insufficient Information
MAUDE report 22814434 ↗InjuryJan 31, 2024Material Separation; Material Separation
IT WAS REPORTED THAT: THE 3-0 SILK WITH CURVED NEEDLE THAT COMES IN THE ARROWGARD BLUE TWO LUMEN HEMODIALYSIS CATHETERIZATION KIT, SIZE 14FR 20CM. THE SUTURE NEEDLE BROKE OFF AND WAS LEFT IN THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE IR SUITES FOR REMOVAL OF THE NEEDLE. THE PATIENT REMAINED STABLE THROUGHOUT.
Patient problems: Foreign Body In Patient
MAUDE report 18612786 ↗
Other Catheter, hemodialysis, triple lumen, non-implanted devices
- Power-Trialysis catheter 5605150Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls13 reports
- Power-Trialysis catheter 5605240Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls8 reports
- MAHURKAR 8888101002HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls1 death8 reports
- MAHURKAR 8888102003HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- Power-Trialysis catheter 5615200Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- Power-Trialysis Slim-Cath catheter 5855240Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- MAHURKAR 8888101003HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- MAHURKAR 8888102004HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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