RapidCross™ A14BX025210170 (UDI 00763000756703)Recalls & reported problems
Medtronic, Inc. · PTA A14BX025210170 RAPIDCROSS V05 · Class 2
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 00763000756703), received between Aug 15, 2025 and Aug 15, 2025 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
InjuryAug 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A PHYSICIAN USED A RAPIDCROSS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON TO TREAT A CALCIFIED LESION IN THE LEFT MID ANTERIOR TIBIAL ARTERY BELOW THE KNEE. A 6FR SHEATH WAS USED. THE BALLOON WAS INFLATED WITH A 50/50 CONTRAST SOLUTION USING A NON-MEDTRONIC INFLATION DEVICE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE VESSEL WAS POST-DILATED. THE BALLOON WAS USED AND SUCCESSFULLY WENT UP AND DEFLATED TO TREAT THE AT. IT WAS REPORTED THAT THE BALLOON DETACHED FROM THE CATHETER SHAFT AND WAS LEFT IN THE SUPERFICIAL FEMORAL ARTERY. IMAGING WAS PERFORMED, INCLUDING A PICTURE TAKEN TO CONFIRM THE BALLOON'S LOCATION IN THE SUPERFICIAL FEMORAL ARTERY. THE PROCEDURE WAS EXTENDED AFTER THE PHYSICIAN REALIZED THAT THE BALLOON WAS NO LONGER ATTACHED TO CATHETER SHAFT. TWO OPEN CELL STENTS WERE DEPLOYED INTO THE SUPERFICIAL FEMORAL ARTERY TO COMPRESS THE BALLOON AGAINST THE ARTERIAL WALL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22815895 ↗
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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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