POWERFLEX 4401006XRecalls & reported problems
Cordis Corporation · POWERFLEXPRO 10MM6CM 135 · 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 20705032060087), received between Jun 24, 2022 and Jun 24, 2022 — 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 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.
MalfunctionJun 24, 2022Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A POWERFLEX PRO 10MMX6CM 135CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST AFTER FILLING. THE BALLOON RUPTURED/BURST AT BELOW RBP. THE PROCEDURE WAS COMPLETED BY USING ANOTHER UNKNOWN NON CORDIS BALLOON. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT AND THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS BEING USED FOR POST-DILATION. THE LESION HAD LITTLE CALCIFICATION AND NO TORTUOSITY. THE LESION HAD AN 88% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE BALLOON RUPTURED/BURST AT BELOW RBP. THE BALLOON PASSED THROUGH A STENT BUT DID NOT RUPTURE IN THE STENT. THE CONTRAST TO SALINE RATIO USED WAS ONE TO ONE. AN UNKNOWN INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION AND THE CATHETER WAS NEVER IN AN ACUTE BEND. THE PRODUCT WAS STORED PROPERLY AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14803150 ↗
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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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