ARROW IPN055217Recalls & reported problems
Teleflex Incorporated · Arterial Catheterization Set · Class 2
All models of ARROW (1494)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902146394), received between Apr 22, 2021 and Apr 22, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Unable to Obtain Readings” (2 reports).
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.
Most reported problems
Device problems
- Unable to Obtain Readings2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2021Unable to Obtain Readings; Unable to Obtain Readings
THE COMPLAINT IS REPORTED AS: AFTER INSERTION OF THE ARTERIAL CATHETER, IT WAS OBSERVED THAT THE PRESSURE READING WAS NO LONGER FUNCTIONAL AFTER 72 HOURS OF USE. THE MONITORING OF THE PRESSURE WAS THEN IMPOSSIBLE AND ARTERIAL SAMPLING WAS PERFORMED BY PUNCTURE. THERE WAS NO PATIENT INJURY. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11706203 ↗MalfunctionApr 22, 2021Unable to Obtain Readings; Unable to Obtain Readings
THE COMPLAINT IS REPORTED AS: AFTER INSERTION OF THE ARTERIAL CATHETER, IT WAS OBSERVED THAT THE PRESSURE READING WAS NO LONGER FUNCTIONAL AFTER 48 HOURS OF USE. THE MONITORING OF THE PRESSURE WAS THEN IMPOSSIBLE AND ARTERIAL SAMPLING WAS PERFORMED BY PUNCTURE. THERE WAS NO PATIENT INJURY. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11706142 ↗
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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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