RapidCross™ A14BX035210170Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000757021), received between Oct 30, 2025 and Aug 10, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Leak/Splash

  It was reported that a plaque lesion in the mid right tibial/popliteal trunk peripheral artery was treated with percutaneous transluminal angioplasty and post-dilation. During the procedure, a balloon leak occurred with the RAPIDCROSS 3.5 mm × 210 mm × 170 cm angioplasty device. A 6 Fr non Medtronic sheath and a 0.014 non Medtronic guidewire were used. The balloon was inflated using a non Medtronic device with 50/50 contrast. The device was safely removed from the patient, and the procedure was completed using a new Medtronic device. During preparation of a second Rapidcross balloon, a hub/Leur leak was noted, the device was not used in the patient. The patient was alive with no injury and no health consequences or impact reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50191959 ↗
• MalfunctionOct 30, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT 100% PLAQUE STENOSIS IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY, A LEAK WAS OBSERVED AT THE HUB/LEUR OF THE RAPIDCROSS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY 3.0MM X 210MM X 170CM BALLOON AND A LEAK WAS OBSERVED AT THE SHAFT OF THE RAPIDCROSS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY 3.5MM X 210MM X 170CM BALLOON. ARTERY DIAMETER REPORTED AS 6MM. THE PROCEDURE INVOLVED THE USE OF A 6FR 45CM NON-MEDTRONIC SHEATH, A 5MM SPIDER FX EMBOLIC PROTECTION DEVICE/GUIDEWIRE. THE VESSEL WAS NOT PRE-DILATED BUT WAS POST-DILATED USING A NANOCROSS 5 X 200 DEVICE. BALLOON INFLATION WAS PERFORMED WITH A NON-MEDTRONIC INFLATION DEVICE USING 50/50 CONTRAST. BOTH DEVICES WERE SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23422343 ↗