POWERFLEX 4401204XRecalls & reported problems
Cordis US Corp. · POWERFLEXPRO 12MM4CM 135 · 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 20705032060186), received between Oct 9, 2019 and Oct 9, 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.
MalfunctionOct 9, 2019Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE POWERFLEX PRO 12MM4CM 135 BALLOON RUPTURED WHEN THE BALLOON DILATED. THERE WERE NO REPORTED PATIENT INJURIES. THE PRODUCT WILL NOT BE RETURNED BECAUSE THE PATIENT HAD INFECTIOUS DISEASES. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9173363 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.