RapidCross™ A14BX030210170 (UDI 00763000756864)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000756864), received between Mar 12, 2025 and Nov 12, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 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 (TERUMO DESTINATION) 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 (MERIT) 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 23530752 ↗
• MalfunctionSep 8, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A CALCIFIED LESION IN THE POSTERIOR TIBIAL ARTERY USING THE RAPIDCROSS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, THE BALLOON BURST BELOW THE RATED BURST PRESSURE DURING INFLATION. THE BALLOON WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW RAPID CROSS BALLOON WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992543 ↗
• InjuryMar 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE RAPIDCROSS BALLOON DEVICE, A DETACHED BALLOON WAS OBSERVED IN THE VESSEL. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST AND A NON-MEDTRONIC SHEATH WAS USED. THE DETACHMENT OCCURRED IN THE RIGHT DISTAL PERIPHERAL ARTERY, SPECIFICALLY WITHIN THE SUPERFICIAL FEMORAL ARTERY, POPLITEAL ARTERY, AND TIBIAL/POPLITEAL TRUNK. AN INTERVENTION WAS REQUIRED TO REMOVE THE DETACHED BALLOON, WHICH WAS SUCCESSFULLY ACCOMPLISHED BY THE PHYSICIAN USING ANOTHER BALLOON SLIGHTLY INFLATED TO GRAB ONTO THE DETACHED BALLOON, PULLING BACK UNTIL IT WAS WITHIN THE SHEATH, AND REMOVING EVERYTHING AS A UNIT. THE PROCEDURE WAS ABORTED FOLLOWING THE REMOVAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21581590 ↗