POWERFLEX 4400708SRecalls & reported problems
Cordis Corporation · POWERFLEXPRO 7MM8CM 80 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 20705032059739), received between Aug 28, 2023 and Aug 28, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, THE FACILITY RECEIVED 10 POWERFLEX PRO BALLOONS (MULTIPLE SIZES) THAT WERE CONTAMINATED WITH DIRT PARTICLES EITHER IN BOX AND OR PACKAGING. FOR FEAR OF CONTAMINATING STERILE FIELD, TWO OF THESE BALLOONS THAT WERE GOING TO BE USED DID NOT GET OPENED BECAUSE PROCEDURAL PERSON NOTICED THE DIRT PRIOR TO OPENING. UPON FURTHER INSPECTION OF REMAINING BALLOONS, THEY DISCOVERED THAT AN ADDITIONAL 8 BALLOONS WERE SIMILARLY CONTAMINATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. IT IS UNKNOWN IF THE DIRT PARTICLES WERE WITHIN THE SEALED PORTION OF THE PACKAGES. THE FACILITY DOES NOT HAVE A RECEIVING BAY. THE DEVICES WERE STORED FOR APPROXIMATELY ONE MONTH PRIOR TO USE. THERE WERE NO DAMAGES NOTED TO THE SHIPPING BOXES. THERE WAS NO DAMAGE NOTED TO THE ACTUAL DEVICE PACKAGING. THE DEVICES WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17634671 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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