POWERFLEX 4401202SRecalls & reported problems
Cordis US Corp. · POWERFLEXPRO 12MM2CM 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 20705032060131), received between Jan 23, 2019 and Jan 23, 2019 — 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.
MalfunctionJan 23, 2019Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 12MM X 2CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS INSERTED AND INFLATED AFTER A NON-CORDIS 6MMX4CM BC WAS INFLATED, HOWEVER THE POWERFLEX PRO RUPTURED AT EIGHT ATMOSPHERES. NO PATIENT INJURY WAS REPORTED. THIS WAS A SHUNT CASE. THE LESION WAS THE LEFT SUBCLAVIAN VEIN WHICH HAD STENOSIS. AN APPROACH WAS MADE FROM THE LEFT BRACHIAL PART WITH A NON-CORDIS 7F SHEATH. A NON-CORDIS GUIDEWIRE CROSSED THE LESION. AFTER THE POWERFLEX PRO RUPTURED, IT WAS REPLACED WITH A NEW NON-CORDIS 10MMX4CM BC AND THE PROCEDURE WAS COMPLETED. THE DEVICE HAS BEEN DISCARDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8271703 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.