Euphora™ EUP22506XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169559936), received between May 13, 2024 and May 13, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

2 FDA recall records name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K143480); 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.

Recalls naming this device

1. Sep 3, 2019Open, Classified

   Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.

   Z-0122-2020 · Root cause: Under Investigation by firm · FDA record ↗

2. Jul 13, 2017Terminated

   Stylette removal difficulties on the Euphora and Solarice products.

   Z-3136-2017 · Root cause: Process design · FDA record ↗

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.

• InjuryMay 13, 2024Burst Container or Vessel; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Burst Container or Vessel; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 80-85% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RESTRAIGHTENED DURING USE. IT WAS REPORTED THAT THE DEVICE DETACHED, CRACKED, OR FRACTURED AT THE BALLOON. IT WAS ALSO REPORTED THAT THE EUPHORA BALLOON WAS INFLATED TO NOMINAL PRESSURE AND IT RUPTURED DUE TO PLAQUE IN THE VESSEL. THE BALLOON CATHETER WAS REMOVED AND IT WAS NOTED THAT THE BALLOON MARKERS AND BALLOON WERE STILL IN THE PATIENT. THE MARKERS AND BALLOON COULD BE SEEN UNDER FLUOROSCOPY. ANOTHER BALLOON WAS USED ALONG WITH A NON-MEDTRONIC GUIDE EXTENSION CATHETER TO TRAP THE DETACHED EUPHORA BALLOON. THE PATIENT IS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19297500 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143480. One submission often covers many models, so check the product and lot details in each record.

• Z-3137-2017 · Jul 13, 2017 · Terminated
  Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.