PowerCross AB18W060060150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684046869), received between Mar 29, 2017 and Jun 2, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2017Device Expiration Issue; Device Expiration Issue

  THE PHYSICIAN USED ONE POWERCROSS BALLOON TO TREAT A LESION IN AN UNKNOWN VESSEL. THE DEVICE WAS REMOVED FROM THE PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS USED SUCCESSFULLY WITH NO PROBLEMS. IT WAS REPORTED THAT THE DEVICE WAS USED APPROXIMATELY ONE MONTH POST EXPIRY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6607710 ↗
• MalfunctionMar 29, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO TREAT PATIENT AT THE PROXIMAL SUPERFICIAL FEMORAL ARTERY USING A POWERCROSS BALLOON. TARGET LESION TYPE WAS REPORTED TO BE "SOFT TISSUE" WITH NO TORTUOSITY, NO CALCIFICATION AND 100% STENOSIS (CTO). IT IS REPORTED THAT BALLOON BURST DURING INFLATION TO 6 ATM WITH AN EVEREST INFLATION DEVICE. IT WAS REPORTED THAT NONE OF THE COMPONENTS DETACHED OR EMBOLIZED. THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED USING ANOTHER BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6442428 ↗

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.