RapidCross™ A14BX025040170Recalls & reported problems
Covidien LP · PTA A14BX025040170 RAPIDCROSS V03 · Class 2
All models of RapidCross (26)
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 00821684067369), received between Jan 4, 2018 and Jan 4, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 4, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
A RAPIDCROSS PTA BALLOON DILATATION CATHETER WAS USED WITH A .014 X 300 NON-MEDTRONIC GUIDEWIRE AND A 6FR X 90 CM NON-MEDTRONIC SHEATH IN THE RIGHT FEMORAL ARTERY AND DESCENDING AORTA TO PERFORM AN INTERVENTION IN A PATIENT¿S RIGHT RADIAL ARTERY BYPASS. THE BALLOON WAS SUCCESSFULLY PLACED OVER THE WIRE AND DEPLOYED IN THE RADIAL BYPASS. DURING THE REMOVAL OF THE BALLOON OVER THE WIRE, IT WAS NOTED THE WIRE HAD LOOPED INTO THE DESCENDING AORTA. AN ATTEMPT WAS MADE TO STRAIGHTEN OUT THE LOOP IN THE WIRE BY SLIDING THE BALLOON CATHETER BACK AND FORTH. WHEN THE CATHETER WAS REMOVED, IT WAS FOUND THAT APPROXIMATELY 30 CM OF THE BALLOON CATHETER WITH THE BALLOON ATTACHED SHEARED OFF INTO THE DESCENDING AORTA. THE 6 FR SHEATH WAS REMOVED AND CUT TO TRY AND LOCATED THE MISSING CATHETER PIECE. THE SHEARED PIECE WAS LOCATED UNDER FLUOROSCOPY BY LOCATING THE BALLOON MARKERS AND REMOVED WITH A NON-MEDTRONIC SNARE DEVICE. THE PHYSICIAN EXAMINED ALL EQUIPMENT TO ENSURE IT HAD BEEN REMOVED ENTIRELY FROM THE BODY. NO PATIENT INJURY WAS REPORTED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7166535 ↗
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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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