POWERFLEX 4200080SRecalls & reported problems
Cordis Corporation · POWERFLEX P3 F5 10X8 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 20705032003923), received between Mar 18, 2024 and Mar 18, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
1 other recall cover devices cleared under the same FDA submission (K032737); they may or may not involve this specific model.
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.
Reports received per month
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.
MalfunctionMar 18, 2024Leak/Splash; Leak/Splash
AS REPORTED, THE BALLOON OF A 10MM X 8CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WOULD NOT INFLATE PAST 14 ATMOSPHERES (ATM). AFTER REMOVING THE BALLOON FROM THE PATIENT, A LEAKAGE AROUND THE TIP OF THE BALLOON WAS OBSERVED. A NON-CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. AN UNKNOWN 7F CATHETER SHEATH INTRODUCER (CSI) WAS USED DURING THIS PROCEDURE. THE POWERFLEX P3 PTA BALLOON CATHETER WAS INSERTED OVER AN UNKNOWN .035 GLIDE WIRE. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED WITH A 5CC CONTRAST AND 12CC SALINE MIXTURE. AN UNKNOWN 7F CORDIS SHEATH WAS USED FOR ACCESS. A NON-CORDIS GUIDEWIRE WAS USED FOR THIS PROCEDURE. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WAS NOT RETURNED AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18927027 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K032737. One submission often covers many models, so check the product and lot details in each record.
- Z-1477-2020 · Jan 8, 2020 · TerminatedCordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Other CATHETER, PERCUTANEOUS devices
- WATCHMAN FXD Curve™ Access System M635TU80020Boston Scientific Corporation · Catheter, percutaneous1 recall47 deaths654 reports
- NA C315HIS02Medtronic, Inc. · Catheter, percutaneous1 recall369 reports
- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- Velocity Delivery Microcatheter VEL160STR-APenumbra, Inc. · CATHETER, PERCUTANEOUS297 reports
- Guidezilla™ H7493924215050Boston Scientific Corporation · CATHETER, PERCUTANEOUS294 reports
- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 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.
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