ARROW IPN920700Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902196931), received between Aug 12, 2026 and Sep 16, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (3 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.
Reports received per month
Most reported problems
Device problems
- Device Damaged Prior to Use3
- Fracture2
- Material Twisted/Bent1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Fracture; Device Damaged Prior to Use
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787940 ↗MalfunctionSep 16, 2026Fracture; Device Damaged Prior to Use
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787847 ↗MalfunctionSep 3, 2026Device Damaged Prior to Use; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50577125 ↗MalfunctionAug 12, 2026Unraveled Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50227017 ↗
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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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