RapidCross™ A14BX040100170Recalls & reported problems
Medtronic, Inc. · PTA A14BX040100170 RAPIDCROSS V05 · Class 2
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 00763000757120), received between Jul 14, 2025 and Jul 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Inflation 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.
MalfunctionJul 14, 2025Inflation Problem; Difficult to Remove; Inflation Problem; Difficult to Remove
IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED PLAQUE LESION IN THE DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY USING A RAPIDCROSS BALLOON, THE MEDICAL STAFF EXPERIENCED INFLATION DIFFICULTIES AS THE BALLOON COULD NOT BE SEEN INFLATING. WHEN ATTEMPTING TO REMOVE THE DEVICE, IT WOULD NOT PASS THROUGH THE SHEATH, REQUIRING REMOVAL OF BOTH THE SHEATH AND BALLOON AS A UNIT. THE BALLOON CATHETER CAUGHT UPON THE SHEATH DURING WITHDRAWAL, AND THE PROCEDURE WAS ABORTED. THE VESSEL HAD BEEN PRE-DILATED, AND A 6FR NON-MEDTRONIC SHEATH AND .014 NON-MEDTRONIC GUIDEWIRE WERE USED. INFLATION WAS ATTEMPTED WITH A MERRIT INFLATION DEVICE USING 50/50 CONTRAST. THE DEVICE WAS REMOVED SUCCESSFULLY IN TANDEM WITHOUT INJURY OR INTERVENTION, AND NO VESSEL DAMAGE WAS REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22494360 ↗
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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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