PowerCross AB18W050150150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684046821), received between Feb 2, 2018 and Feb 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 16, 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.

• MalfunctionFeb 2, 2018Leak/Splash; Leak/Splash

  THE PHYSICIAN WAS ATTEMPTING TO USE A POWERCROSS PTA BALLOON TO TREAT A 140MM MODERATELY CALCIFIED PLAQUE LESION IN THE DISTAL RIGHT SFA (50% STENOSIS). THE ARTERY HAD A DIAMETER OF 5MM AND WAS MODERATELY TORTUOUS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 6 FR NON-MEDTRONIC SHEATH AND A 0.018" NON-MEDTRONIC GUIDEWIRE. NO RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT DURING THE FIRST INFLATION AT 12 ATM PRESSURE, THE CONTRAST FROM THE BALLOON WAS SEEN SEEPING OUT OF THE BALLOON. THE BALLOON WAS DEFLATED AND REMOVED. NO TEAR ON BALLOON WAS OBSERVED, BALLOON REMAINED INTACT. ANOTHER POWERCROSS PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7236534 ↗

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.