CROSPERIO RX BD-B25200LRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04540778163454), received between Mar 30, 2022 and Nov 10, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (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

Recent adverse event reports

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

• InjuryNov 10, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER WAS PERFORMING A CONTRALATERAL SFA ANGIOPLASTY. THEY HAD A COOK SHEATH UP AND OVER AND HAD THE CROSPERIO IN THE SFA. THEY HAD INFLATED THE BALLOON AND HAD THEN TRIED TO ADVANCE IT MORE DISTAL. BALLOON WOULD NOT ADVANCE AND THEY REPORTED THAT WHEN THEY TRIED TO THEN REMOVE THE BALLOON IT SHEARED OFF OF THE BALLOON CATHETER. THEY REPORTED THEY FELT RESISTANCE UPON TRYING TO REMOVE THE BALLOON AND HAD TO PULL HARD TO GET IT OUT. THE BALLOON WAS UNATTACHED AT THIS POINT AND ENDED UP IN THE PATIENTS PROFUNDA. PATIENT WAS TAKEN TO SURGERY WHERE BALLOON WAS SUCCESSFULLY REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15777264 ↗
• InjuryMar 30, 2022Material Fragmentation; Material Fragmentation

  THE PRODUCT WAS USED FOR TREATMENT OF THE POSTERIOR TIBIAL ARTERY. THE PATIENT WAS A DIALYSIS PATIENT WITH STRONG CALCIFICATION AND BALLOON DILATATION WAS INSUFFICIENT EVEN WHEN BALLOON PRESSURE WAS INCREASED UP TO THE RBP. CONSIDERING THE POSSIBILITY OF CATHETER BREAKAGE, THE DOCTOR TRIED VARIOUS METHODS TO REMOVE THE SNAGGING AT THE DISTAL TIP WITHOUT FURTHER REMOVAL OF THE CATHETER. HOWEVER, THE DISTAL TIP SNAGGING COULD NOT BE RELEASED AT ALL, AND WHILE TRYING VARIOUS METHODS, THE BALLOON PORTION BECAME DETACHED, LEAVING AN ESTIMATED 10 CM OF THE BALLOON PORTION AND THE TIP PORTION REMAINING INSIDE THE BODY. IT WAS DETERMINED THAT THE PRODUCT REMAINING IN THE BODY COULD NOT BE RECOVERED, AND THE PLAN WAS TO MONITOR THE BLOOD FLOW THROUGH THE BODY ON A FOLLOW-UP BASIS. THE ANTERIOR TIBIAL ARTERY WAS TREATED ON THE SAME DAY, AND BLOOD FLOW WAS STILL FLOWING TO THE FINGERTIPS. THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 13947903 ↗