Fortrex A35HPV10080080Recalls & reported problems
Covidien LP · 0.035 IN OTW PTA Balloon Catheter · Class 2
All models of Fortrex (34)
Data updated Oct 18, 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 00821684057841), received between Jun 11, 2018 and Jun 11, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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 18, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2018Burst Container or Vessel; Burst Container or Vessel
THE PHYSICIAN WAS USING A FORTREX BALLOON TO TREAT A 80MM MODERATELY CALCIFIED AXIAL ARTERY LESION. THE ARTERY HAD A 10MM DIAMETER AND LOW TORTUOSITY. THE PROCEDURE USED A 7 FR NON MDT (BSC) SHEATH AND A 0.035" NON MDT (BSC GLIDEWIRE). THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE DILATED. CONTRAST AND SALINE INFLATION FLUID WAS USED WITH A NON MDT (BSC) DEVICE. THERE WAS NO RESISTANCE ADVANCING THE DEVICE AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. BALLOON BURST AT 16 ATM DURING INITIAL INFLATION. BURST BALLOON WAS UNABLE TO BE RETRACTED THROUGH SHEATH, SO BALLOON, WIRE AND SHEATH ALL HAD TO BE REMOVED THUS ENDING THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7585914 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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