PowerCross AB18W030060150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684046623), received between Jul 13, 2018 and Jul 13, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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.

• MalfunctionJul 13, 2018Component Missing; Detachment of Device or Device Component; Device Markings/Labelling Problem; Component Missing; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE BALLOON ANGIOPLASTY TREAT A 100MM PLAQUE LESION WITH 75% STENOSIS AND NO CALCIFICATION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA) USING A POWERCROSS DEVICE AND A NITREX 18 300CM GUIDEWIRE. NO TORTUOSITY WAS REPORTED. PRE-DILATION WAS PERFORMED WITH 3X60 DEVICE (8ATMS AND ONE INFLATION). AFTER PRE-DILATION A 4X120 DEVICE WAS USED (7 ATM AND 1 INFLATION). THE POWERCROSS BALLOON USUALLY HAS TWO RADIOPAQUE MARKERS BUT IT WAS NOTICED WHILE POSITIONING THE BALLOON THAT THE PROXIMAL MARKER ON THE BALLOON WAS NOT VISIBLE. THE BALLOON WAS GIVEN OPAQUE SHAPE SLIGHTLY TO SEE THE LENGTH OF THE BALLOON. THE ISSUE WAS NOTICED AFTER THE PRODUCT WAS SENT INTO THE PATIENT. THE MARKER WAS NOT INITIALLY VISIBLE IN THE PATIENT AND IT WAS REPORTED THAT IT DID NOT FALL OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED NORMALLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7684711 ↗

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.