ARROW IPN919948Recalls & reported problems
Teleflex Incorporated · Two-Lumen Hemodialysis Catheterization Set with Blue FlexTip(R) Catheter for High Volume Infusions · Class 2
All models of ARROW (1494)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902190502), received between Apr 14, 2026 and Apr 24, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Difficult to Advance1
- Material Too Soft/Flexible1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2026Material Too Soft/Flexible
IT WAS REPORTED THAT: "THE DILATOR IS TOO SOFT. THERE WAS NO REPORTED PATIENT HARM OR INJURY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24978056 ↗MalfunctionApr 22, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT: "(B)(6) 2026, THE PATIENT WAS ON LONG-TERM HEMODIALYSIS WITH A TEMPORARY HEMODIALYSIS CATHETER IN THE RIGHT JUGULAR VEIN. AT THE END OF THE SESSION, THE PLASTIC CONNECTOR ON THE VENOUS SIDE OF THE DIALYSIS TUBING DETACHED AND BECAME IMPACTED AND STUCK AT THE CATHETER HUB. THE ENTIRE LODGED CONNECTOR WAS REMOVED USING FINE STERILE FORCEPS. THE CATHETER WAS FLUSHED WITH NORMAL SALINE AND LOCKED AGAIN WITH A HEPARIN CAP. THERE WAS NO REPORTED PATIENT HARM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954171 ↗MalfunctionApr 14, 2026Difficult to Advance; Material Twisted/Bent
IT WAS REPORTED THAT: "WHEN ADVANCING THE CATHETER OVER THE GUIDEWIRE, THE CATHETER COULD NOT BE INSERTED SMOOTHLY AND KINKED. THE CATHETER WAS UNUSABLE. AFTER REPLACEMENT, THE PUNCTURE WAS SUCCESSFUL. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24870437 ↗
Other Catheter, subclavian devices
- Permcath 8817748001Mozarc Medical US LLC · CATHETER, SUBCLAVIAN2 deaths34 reports
- ARROW IPN030063Teleflex Incorporated · CATHETER, SUBCLAVIAN30 reports
- Hemo-Cath® SL18PMedical Components, Inc. · CATHETER, SUBCLAVIAN1 death25 reports
- Soft-Cell PC-2 Dialysis Catheter Kit 12.5 F x 19 cm 5534190Bard Access Systems, Inc. · CATHETER, SUBCLAVIAN17 reports
- Schon 10800702Angiodynamics, Inc. · CATHETER, SUBCLAVIAN8 reports
- Permcath 8817749001Mozarc Medical US LLC · CATHETER, SUBCLAVIAN7 reports
- ARROW IPN919725Teleflex Incorporated · Catheter, subclavian7 reports
- ARROW IPN919724Teleflex Incorporated · Catheter, subclavian6 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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