POWERFLEX 4400315XRecalls & reported problems
Cordis Corporation · POWERFLEXPRO 3MM15CM 135 · Class 2
All models of POWERFLEX (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032059098), received between Nov 3, 2021 and Mar 8, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Burst Container or Vessel2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2022Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, DURING A PERIPHERAL ANGIOPLASTY THE POWERFLEXPRO 3MM15CM 135 BALLOON CATHETER DID NOT INFLATE. THE DOCTOR NOTICED THAT THE BALLOON WAS PUNCTURED. THE PUNCTURE /CUT NOTICED WAS NOTED DURING USE. THERE WAS NO PATIENT INJURY. ANOTHER POWERFLEX WAS USED WITHOUT PROBLEMS. THE TARGET AND ACCESS SITE WERE FEMORAL. THE DEVICE WAS PREPPED PER THE IFU. THERE WAS NO DIFFICULTY EXPERIENCED WHEN PREPPING THE DEVICE. A CONTRALATERAL APPROACH WAS NOT USED. THE DEVICE WAS NOT BEING USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION. THE PRODUCT, OR ANY OF THE OTHER DEVICES USED WERE NOT RESTERILIZED. THE DEVICE WAS NOT RETURNED FOR EVALUATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13686198 ↗MalfunctionNov 3, 2021Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 3MM 15CM 135CM POWERFLEX BALLOON DID NOT INFLATE AT THE TIME OF THE SURGERY, WHICH MEANS THAT IT WAS PUNCTURED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION. PER THE PRODUCT EVALUATION, RUPTURE/BURST OF THE BALLOON WAS CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12745245 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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