CROSPERIO RX BD-B20200LRRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04540778163430), received between Dec 25, 2016 and Sep 28, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE PATIENT USED THE DEVICE FOR TREATMENT OF THE ANTERIOR TIBIAL ARTERY. AFTER THE TREATMENT, THE PATIENT HAD DIFFICULTY IN REMOVING THE SHEATH DUE TO A KINK OF THE GUIDE WIRE (HEREINAFTER REFERRED TO AS "GW"), AND THE SHEATH WAS MOVED FORWARD WHILE PULLING THE BALLOON TOWARD THE HAND. THE SHEATH WAS MOVED FORWARD WHILE THE BALLOON WAS PULLED TOWARD THE HAND SIDE. AS THE PROCEDURE WAS REPEATED, THE CATHETER SHAFT BROKE AT THE PORT OF THE GW AND THE BALLOON REMAINED ON THE GW. AFTER THAT, BILATERAL CFA CUT-DOWNS WERE PERFORMED. THE REMNANT WAS SUCCESSFULLY REMOVED. ANGIOGRAPHY CONFIRMED COMPLETE REMOVAL OF THE REMNANT AND THE PATIENT WAS STABILIZED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17840867 ↗
• InjuryDec 4, 2017Material Separation; Use of Device Problem; Device Handling Problem; Material Separation; Use of Device Problem; Device Handling Problem

  THE CASE WAS A PTA ON THE LOWER EXTREMITY. THE GUIDEWIRE PASSED THE LESION AND THE DR. DECIDED ON PRE-DILATATION PRIOR TO STENT PLACEMENT. A 0.014 INCH BALLOON CATHETER, THE DEVICE CONCERNED, WAS USED. THE BALLOON BURST PRIOR TO COMPLETE INFLATION. THE BALLOON CATHETER WAS REMOVED BUT IT WAS OBSERVED THAT SOME PART OF THE BALLOON WAS MISSING. THE FRACTURED BALLOON PORTION WAS FOUND AT THE LESION, AND THE DR. TRIED BUT FAILED TO REMOVE IT OUT OF THE LESION. A STENT WAS ADVANCED OVER AREA AND DEPLOYED OVER THE BALLOON FRAGMENT. A 0.035 INCH BALLOON CATHETER WAS USED FOR POST STENT DILATATION, AND THE EXAM COMPLETED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7081851 ↗
• InjuryJun 22, 2017Material Separation; Use of Device Problem; Device Handling Problem; Material Separation; Use of Device Problem; Device Handling Problem

  THIS DEVICE, "CROSPERIO RX" PTA BALLOON DILATATION CATHETER (2.0MM X 200MM), WAS EMPLOYED FOR A PTA OF THE POSTERIOR TIBIAL ARTERY. THE PATIENT'S PROFILE IN DETAIL WAS NOT AVAILABLE. THE LESION WAS CALCIFIED. BEFORE PERFORMING A BALLOON DILATATION, THE LESION WAS CROSSED BY 0.014" GUIDEWIRE (GW), "GLADIUS" (ASAHI INTECC, CO.), THROUGH 6-FR GUIDING SHEATH, "DESTINATION" (TERUMO, CO.). THEN, THE GW WAS REPLACED WITH ANOTHER 0.014" GW, "CRUISE" (ASAHI INTECC, CO.), AND THE LESION WAS BALLOON-DILATED CONSECUTIVELY WITH "JADE 1.5MM X 80MM" (ORBUSNEICH MEDICAL, INC.), THIS DEVICE, A CUTTING BALLOON 3.0MM X 80MM (THE MANUFACTURER UNKNOWN), AND THEN WITH THIS DEVICE AGAIN. THE BALLOON OF THIS DEVICE RUPTURED IN THE SECOND USE. THE PHYSICIAN TRIED TO RETRIEVE THIS DEVICE OUT OF THE PATIENT, BUT THE DISTAL PORTION OF THE BALLOON GOT STUCK IN THE LESION. FURTHER ATTEMPT TO PULL OUT THE DEVICE RESULTED IN TORN OFF THE DISTAL PORTION OF THE BALLOON WHICH REMAINED IN THE PATIENT'S VESSEL. THE PHYSICIAN TRIED BUT FAILED TO RETRIEVE THE TORN OFF BALLOON PORTION BY USING ANOTHER CATHETER DEVICE, AND PRESSED TO FIX IT ONTO THE VESSEL'S WALL BY USING A STENT TO COMPLETE THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6662463 ↗
• InjuryDec 25, 2016Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  THE DR. WAS PERFORMING A LOWER EXTREMITY INTERVENTION UTILIZING SEVERAL PTA BALLOONS. HE USED 4 CROSPERIO RX PTA BALLOON CATHETERS WITHOUT PROBLEMS. THEN, AT ONE POINT, HE WAS UNABLE TO INFLATE A 2MM X 200MM CROSPERIO RX IN THE PATIENT'S ANTERIOR TIBIAL ARTERY. UPON CLOSER EXAMINATION VIA VASCULAR ULTRASOUND, THE DR. IDENTIFIED A FOREIGN OBJECT IN THE PATIENT'S ANTERIOR TIBIAL ARTERY. IT WAS VERY DIFFICULT TO SEE DURING IMAGING; THERE WERE NO MARKERS, BRAIDING ETC. POST CASE, THE DR. REPORTED THAT THE SCRUB TECH REMOVED THE STYLET, BUT DID NOT REMOVE THE BALLOON PROTECTIVE TUBE ON ONE OF THE PTA BALLOON. THE SCRUB TECH INSERTED THE PTA BALLOON (WITH THE BALLOON PROTECTIVE TUBE STILL IN PLACE) OVER THE GUIDEWIRE AND THE DR. ADVANCED IT INTO THE 5FR INTRODUCER SHEATH. HE WAS UNABLE TO INFLATE THE PTA BALLOON, SO IT WAS WITHDRAWN. THE BALLOON PROTECTIVE TUBE MUST HAVE COME OFF THE BALLOON, DISLODGING IN THE PATIENT'S ANTERIOR TIBIAL ARTERY. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE BALLOON PROTECTIVE TUBE, BUT WERE UNSUCCESSFUL IN THIS CASE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6203734 ↗