POWERFLEX 4400615SRecalls & reported problems
Cordis US Corp. · POWERFLEXPRO 6MM15CM 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 20705032059609), received between Sep 24, 2020 and Sep 24, 2020 — 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.
MalfunctionSep 24, 2020Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 6MM X 15CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED BUT IT RUPTURED AT 12 ATMOSPHERIC PRESSURE (ATM) DURING ITS SECOND INFLATION. THEREFORE, ANOTHER POWERFLEX PRO (6MM X 10CM X 80CM) WAS USED BUT IT RUPTURED AT 10 ATM DURING ITS INITIAL INFLATION. A NEW 6MM BALLOON CATHETER (NON-CORDIS) WAS USED AND IT INFLATED AT THE LESION. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY WHICH HAD SEVERE CALCIFICATION AND CONTINUOUS STENOSIS. AN IPSILATERAL APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A NON-CORDIS SHEATH (6F 26CM). A NON-CORDIS GUIDEWIRE CROSSED THE LESION. THE GUIDEWIRE WAS REPLACED WITH ANOTHER NON-CORDIS GUIDEWIRE. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS DEVICES WERE DISCARDED IN THE HOSPITAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10579501 ↗
Other Catheter, angioplasty, peripheral, transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page