PowerCross AB18W060100150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684046883), received between Mar 8, 2018 and Mar 8, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

1 FDA recall record name this device's identifier.

1 other recall 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 10, 2016Terminated

   Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an out of specification condition was observed. The catheter outer shafts were pinched and deformed at the proximal balloon bond. Bench testing of affected devices showed that this resulted in either the inability to inflate the device, a slow deflation, or the inability to deflate the device post expansion.

   Z-0892-2017 · Root cause: Process control · FDA record ↗

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.

• InjuryMar 8, 2018Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS ATTEMPTING TO USE A POWERCROSS BALLOON TO TREAT A SEVERELY CALCIFIED AND SLIGHTLY TORTUOUS MID LEFT ILIAC ARTERY LESION EXHIBITING 100% OCCLUSION. THE DEVICE WAS USED WITH A NON-MDT SHEATH <(>&<)> GUIDEWIRE. NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS REMOVED FROM ITS PACKAGING WITHOUT ISSUE AND INSPECTED WITH NO ISSUES NOTED. THE IFU WAS FOLLOWED DURING THE PROCEDURE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND THAT EXCESSIVE FORCE WAS USED DURING DELIVERY OF THE DEVICE. DURING THE INITIAL BALLOON INFLATION, USING A SYRINGE AND CONTRAST/SALINE MIX, A BALLOON BURST OCCURRED. FOLLOWING THIS, IT WAS REPORTED THAT A FRAGMENT OF THE BALLOON REMAINED IN THE PATIENT. THE PATIENT ATTENDED THE OR WHERE THE BALLOON FRAGMENT WAS REMOVED BY COMMON FEMORAL ENDARTERECTOMY. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem

  MAUDE report 7323289 ↗

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-1552-2016 · Mar 29, 2016 · Terminated
  ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.