OPTA 4196040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032003343), received between Oct 14, 2020 and Oct 14, 2020 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2020Leak/Splash; Leak/Splash

  AS REPORTED, A LEAKAGE WAS NOTICED AT THE TOP OF 5F 6X4 80 OPTA PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER AFTER IT WAS REMOVED FROM THE PATIENT¿S BODY AND EXAMINED. THE BALLOON WAS ALSO NOTED TO BE STIFF WHEN LOADING ONTO THE UNKNOWN WIRE, THERE WAS A LOT OF RESISTANCE FELT PRIOR TO INFLATION. WHEN THE BALLOON WAS INFLATED, IT WOULD NOT MAINTAIN ITS ATMOSPHERIC PRESSURE. A NEW 6MMX4CMX80CM OPTA PRO BALLOON WAS OPENED, AND IT WORKED PERFECTLY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PROPERLY OPENED IN STERILE FIELD. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE PHYSICIAN STATES TO HAVE FELT A SIGNIFICANT AMOUNT OF RESISTANCE LOADING THE BALLOON ONTO THE WIRE. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED AT THE SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10679946 ↗

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 · Terminated
  Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S