AMPHIRION DEEP AMP020150152Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477045849), received between Apr 27, 2017 and Apr 27, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K083919); 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.

• MalfunctionApr 27, 2017Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS TREATING A LESION IN THE TIBIAL/POPLITEAL TRUNK USING AMPHIRION DEEP DILATATION BALLOON CATHETER. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED REMOVAL DIFFICULTIES FOLLOWING BALLOON INFLATION. THE CATHETER/DELIVERY SYSTEM DEFORMED. THE CATHETER WAS REMOVED WITH SHEATH. THE BALLOON WENT DOWN TO LESION (ANTERIOR TIBIAL) WITHOUT INCIDENT. INFLATED AND CAME DOWN WITHOUT INCIDENT. THE PROBLEM OCCURRED WHILE REMOVING THE BALLOON. ANTEGRADE STICK WITH A 5FR RAABE COOK SHEATH. THE BALLOON GOT STUCK IN THE VALVE OF THE SHEATH. BALLOON CATHETER BROKE WHILE PULLING IT OUT. PHYSICIAN GRABBED THE BROKEN PORTION OF THE BALLOON CATHETER AND PULLED IT ALL OUT WITH THE WIRE. IT WAS REPORTED THAT THE PATIENT WAS OBESE AND THE SHEATH COULD HAVE KINKED CAUSING THE BALLOON DIFFICULTIES IN BEING REMOVED. BY THE TIME THE BALLOON BROKE AND THE PHYSICIAN GRABBING THE OTHER PORTION OF THE CATHETER AND PULLING IT OUT, HAPPENED SO QUICK IT WAS DIFFICULT TO TELL WHAT HAPPENED. THERE WAS NO INJURY TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6525978 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083919. One submission often covers many models, so check the product and lot details in each record.

• Z-0243-2016 · Oct 23, 2015 · Terminated
  Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210152 AMP020040152 AMP025040152 AMP025150152 AM