POWERFLEX 4400412XRecalls & reported problems
Cordis US Corp. · POWERFLEXPRO 4MM12CM 135 · Class 2
All models of POWERFLEX (56)
Data updated Oct 16, 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 20705032059234), received between Apr 6, 2023 and Apr 6, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Leak/Splash1
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.
MalfunctionApr 6, 2023Leak/Splash; Leak/Splash
AS REPORTED, THE BALLOON OF A 4 MM X 12 CM 135 CM POWERFLEX PRO BALLOON CATHETER WAS FOUND TO HAVE AN AIR LEAKAGE WHEN IT WAS INFLATED BY THE PRESSURE PUMP, AFTER THE BALLOON WAS IMPLANTED INTO THE BODY. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS NOT PUT INTO AN ACUTE BEND AT ANY POINT DURING THE PROCEDURE. THE DEVICE WAS ABLE TO CROSS THE LESION. THE DEVICE DID NOT KINK AT ANY TIME DURING THE PROCEDURE. THERE WERE NO ANOMALIES NOTED AFTER THE DEVICE WAS DELIVERED TO THE LESION. THERE WAS NO RESISTANCE WHEN WITHDRAWING THE DEVICE. THE TARGET SITE VESSEL WAS THE LOWER EXTREMITY ARTERY. THERE WAS NO CALCIFICATION AND NO TORTUOSITY. THE STENOSIS WAS MODERATE. THERE WERE NO ACUTE ANGLE AND BIFURCATING. THE VESSEL ACCESSING TARGET SITE HAD NO CALCIUM AND TORTUOSITY. THE VESSEL ACCESSING TARGET SITE HAD MODERATE STENOSIS, NO ACUTE ANGLE OR BIFURCATING. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO CONTRALATERAL APPROACH USED. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16688673 ↗
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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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