ARROW IPN030315Recalls & 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 00801902102768), received between Aug 2, 2023 and Aug 18, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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
- Deformation Due to Compressive Stress1
- Material Frayed1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2025Material Frayed; Material Frayed
IT WAS REPORTED THAT "DEFECTIVE GUIDE WIRE, PRESENTING FRAYING DURING INSERTION INTO THE NEEDLE. IT WAS NECESSARY TO USE ANOTHER KIT." ADDITIONAL DETAILS ARE UNKNOWN AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 22827104 ↗MalfunctionAug 2, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
THE COMPLAINT IS REPORTED AS: "THE PHYSICIAN REPORTS THAT WHEN OPENING THE FEMORAL SAC KIT, SHE SAW THAT THE GUIDE WIRE WAS CRUMPLED AND BENT INTO 2 PARTS. REQUESTED ANOTHER KIT FOR THE PROCEDURE WITHOUT HARMING THE HEALTH AND SAFETY OF THE PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17442386 ↗
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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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