PowerCross AB18W020100090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684046104), received between Nov 8, 2017 and Nov 8, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K093286); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2017Deflation Problem; Inflation Problem; Leak/Splash; Deflation Problem; Inflation Problem; Leak/Splash

  THE PHYSICIAN WAS ATTEMPTING TO USE A POWERCROSS PTA BALLOON TO TREAT A SLIGHTLY TORTUOUS AND SLIGHTLY CALCIFIED DISTAL RIGHT ANTERIOR TIBIAL ARTERY EXHIBITING 50% STENOSIS. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED INFLATION DIFFICULTIES AND THAT A CONTRAST LEAK WAS NOTED AT THE PROXIMAL END OF THE BALLOON. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO DEFLATE THE BALLOON MANUALLY AND THAT THE BALLOON WAS SLOW TO DEFLATE BY ITSELF BEFORE THE BALLOON WAS REMOVED FROM THE PATIENT. THE PHYSICIAN USED ANOTHER BALLOON TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7012254 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093286. One submission often covers many models, so check the product and lot details in each record.

• Z-0892-2017 · Nov 10, 2016 · Terminated
  ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, po
• Z-1552-2016 · Mar 29, 2016 · Terminated
  ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.