RapidCross™ A14BX025100170Recalls & reported problems
Covidien LP · PTA A14BX025100170 RAPIDCROSS V04 · Class 2
All models of RapidCross (26)
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 00763000110819), received between Jan 19, 2023 and Jan 19, 2023 — 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 16, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2023Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A RAPIDCROSS BALLOON TO TREAT A LESION AT THE PERONEAL ARTERY. THE IFU WAS FOLLOWED, HOWEVER PHYSICIAN DID NOTE CALCIFIC DIFFUSED DISEASE IN ALL THREE TIBIAL ARTERIES. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE AND 50% CONTRAST, 50% HEPARINIZED SALINE. IT WAS REPORTED THAT THERE WAS A BALLOON BURST AT 6 ATM. THE BALLOON BROKE OFF OF THE CATHETER AND WAS LEFT INSIDE OF THE PATIENT¿S BODY. IT OBSTRUCTED THE PERINEAL ARTERY AND WAS LEFT THERE. THE OTHER TWO TIBIAL ARTERIES WERE PATENT. THE ENTIRE VESSEL WAS LOST DUE TO BEING UNABLE TO RETRIEVE THE BROKEN OFF BALLOON. IT IS UNKNOWN IF THE BALLOON FRAGMENTED BECAUSE THE BALLOON BROKE OFF OF THE CATHETER AND STILL REMAINS IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16203266 ↗
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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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