ARROW IPN030324Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801902102799), received between Dec 7, 2021 and Mar 19, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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
- Material Twisted/Bent3
- Deformation Due to Compressive Stress2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body In Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2026Material Twisted/Bent
IT WAS REPORTED THAT "PRODUCTS WITH CREASE MARKS OR FOLDS IN THEIR PHYSICAL APPEARANCE INSIDE THE ORIGINAL PACKAGING." THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24638854 ↗InjuryJul 16, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "WHEN THE GUIDEWIRE WAS REMOVED DURING THE PROCEDURE, IT BENT AND GOT STUCK IN THE MUSCLE TISSUE, REQUIRING THE TISSUE TO BE OPENED TO REMOVE IT AND THEN SUTURED." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".
Patient problems: Foreign Body In Patient
MAUDE report 22523699 ↗MalfunctionMay 7, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED " WE FOUND THE PRODUCT AND PACKAGING DAMAGED (CRUSHED) INSIDE THE BOX DURING THE RECEIPT AND LABELING INSPECTION". THIS WAS FOUND PRIOR TO USE. THEREFORE NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19257297 ↗MalfunctionDec 7, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
THE COMPLAINT IS REPORTED AS: DURING INSPECTION OF THE STOCK FOR NATIONALIZATION LABEL IT OBSERVED THAT THE GUIDEIS NOT STRAIGHT. PACKAGING IS CLOSED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12954993 ↗MalfunctionDec 7, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
THE COMPLAINT IS REPORTED AS: DURING INSPECTION OF THE STOCK FOR NATIONALIZATION LABEL IT OBSERVED THAT THE GUIDEIS NOT STRAIGHT. PACKAGING IS CLOSED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12954962 ↗
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- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
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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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