ARROW IPN036174Recalls & reported problems
Teleflex Incorporated · Arterial Catheterization Kit · Class 2
All models of ARROW (1494)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902111965), received between Oct 24, 2024 and Oct 24, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
- Material Too Rigid or Stiff1
Patient problems
- Hematoma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2024Material Too Rigid or Stiff; Difficult to Advance; Material Too Rigid or Stiff; Difficult to Advance
IT WAS REPORTED "GUIDE WIRE IS TOO SHORT, TOO STIFF TO DO NOT SLIP INTO THE VESSEL". "THE PATIENT DID GET A BIG HEMATOMA, UNABLE TO PLACE THE LINE." ADDITIONAL INFORMATION REPORTS THERE WAS SCAR TISSUE PRESENT PRIOR TO INSERTION. THE HEMATOMA REQUIRED MANUAL COMPRESSION. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE, NO NERVE DAMAGE".
Patient problems: Hematoma
MAUDE report 20523954 ↗
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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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