Fortrex™ A35HPV09080080Recalls & reported problems
Covidien LP · PTA A35HPV09080080 FORTREX V02 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000106317), received between May 29, 2019 and May 29, 2019 — classified as 1 injury.
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.
InjuryMay 29, 2019Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN USED A FORTREX BALLOON WITH A NON-MEDTRONIC (BSC) 7FR SHEATH AND .035 (TERUMO GLIDEWIRE) WIRE DURING TREATMENT A FIBROUS LESION IN THE PATIENTS MID CEPHALON VEIN. PHYSICIAN ATTEMPTING TO TREAT IN-STENT STENOSIS OF THE VEIN (DIAMETER REPORTED AS 9MM). IFU WAS FOLLOWED DURING PREP. DEVICE PREPPED WITHOUT ISSUE. DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. A NON-MEDTRONIC (BSC) INFLATION DEVICE WAS USED WITH A CONTRAST SALINE MIX FOR BALLOON INFLATION. IT IS REPORTED THAT A CIRCUMFERENTIAL BALLOON BURST OCCURRED. FOLLOWING THIS THE DISTAL TIP OF THE BALLOON SEPARATED FROM THE CATHETER. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE REMAINING BALLOON MATERIAL THAT WAS STILL ON THE WIRE. ULTIMATELY ANOTHER ACCESS POINT AND A 12 FRENCH SHEATH WERE USED TO RETRIEVE THE BALLOON MATERIAL AND TIP SUCCESSFULLY. PATIENT REPORTED AS STABLE AND HAS BEEN RELEASED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8649023 ↗
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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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