RapidCross™ A14BX035120170Recalls & reported problems
Covidien LP · PTA A14BX035120170 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 00763000111151), received between Oct 3, 2022 and Oct 3, 2022 — 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
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2022Burst Container or Vessel; Burst Container or Vessel
A PHYSICIAN WAS ATTEMPTING TO USE A RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER FOR TREATMENT OF A 60MM CALCIFIED LESION IN THE LEFT TIBIAL/POPLITEAL TRUNK. THE ARTERY DIAMETER WAS 3.5MM WITH MODERATE TORTUOSITY AND CALCIFICATION. THE DEVICE WAS PREPPED WIT NO ISSUES IDENTIFIED. THE BALLOON WAS INFLATED WITH SALINE. IT WAS REPORTED A LONGITUDINAL BURST OCCURRED DURING INFLATION. ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETE BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND LASER ATHERECTOMY WAS CARRIED OUT. NO PATIENT INJURY WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 15527809 ↗
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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 13, 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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