RapidCross™ A14BX025150170Recalls & reported problems
Covidien LP · PTA A14BX025150170 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000110857), received between May 14, 2024 and May 14, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
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.
InjuryMay 14, 2024Deflation Problem; Deflation Problem
PHYSICIAN ATTEMPTED TO USE A RAPID CROSS PTA BALLOON DILATATION CATHETER WITH A 45CM 6FR NON-MEDTRONIC SHEATH AND A .014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A FIBROUS LESION IN PATIENTS RIGHT DISTAL ANTERIOR TIBIAL ARTERY (ATA). THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE-DILATED WITH THE RAPIDCROSS PTA BALLOON. THE VESSEL WAS NOT POST-DILATED. A MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST INFLATION FLUID WAS USED. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. DEFLATION DIFFICULTIES WERE REPORTED. NO ISSUES WERE NOTED DURING INFLATION. BALLOON WAS TAKEN TO NOMINAL INFLATION PRESSURE BUT WOULD NOT DEFLATE. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. THE PHYSICIAN CUT THE HUB OFF THE CATHETER TO ALLOW FOR BALLOON DEFLATION. THE BALLOON WAS EVENTUALLY FULLY DEFLATED FOR REMOV
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19309539 ↗
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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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