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POWERFLEX 4400402SRecalls & reported problems

Cordis US Corp. · POWERFLEXPRO 4MM2CM 80 · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032059128), received between Nov 16, 2018 and Nov 16, 2018 — classified as 1 malfunction.

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

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.

Most reported problems

Device problems

  • Burst Container or Vessel1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionNov 16, 2018Burst Container or Vessel; Burst Container or Vessel

    DURING USE, IT WAS REPORTED THAT THE POWER FLEX PRO BALLOON CATHETER WAS LEAKING WHEN IT WAS INFLATED IN THE PATIENT AND THERE WAS DIFFICULTY REMOVING THE BALLOON ON THE GUIDEWIRE. THERE WAS NO PATIENT INJURY. THEREFORE, THE POWER FLEX PRO AND THE UNKNOWN GUIDEWIRE WAS REMOVED TOGETHER. THE BALLOON WAS REPLACED WITH A NEW POWER FLEX PRO (4*40), ALONG WITH A NEW GUIDEWIRE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A POWER FLEX PRO WAS INSERTED AND WAS INFLATED AT TEN ATMOSPHERE (10 ATM) DURING ITS INITIAL INFLATION. HOWEVER IT WAS CONFIRMED THAT A LITTLE OF CONTRAST MEDIUM LEAKED FROM THE BALLOON EDGE. IT WAS INFLATED AT 10 ATM DURING ITS SECOND INFLATION BUT THE SAME ISSUE OCCURRED AGAIN AND IT COULD NOT BE INFLATED. THE PHYSICIAN TRIED TO REMOVE THE POWER FLEX PRO BUT IT COULD NOT BE REMOVED AS THE WIRE GOT STUCK WITH THE GUIDEWIRE LUMEN. SO IT WAS REMOVED TOGETHER. THE PHYSICIAN TRIED TO REMOVE THE GUIDEWIRE OUTSIDE THE PATIENT BUT COULD NOT. THE DISTAL PORTION OF THE SUPERFICIAL FEMORAL ARTERY WHICH WAS NOT TORTUOUS, OR CALCIFIED WITH EIGHTY PERCENT STENOSIS. AND TO WHAT DEGREE. THERE WERE NO DIFFICULTY INFLATING THE BALLOON. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FR

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8079536 ↗

Other Catheter, angioplasty, peripheral, transluminal devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.