Euphora™ EUP3030XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169560185), received between Jul 25, 2024 and Jul 25, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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.

• MalfunctionJul 25, 2024Deflation Problem; Difficult to Remove; Material Deformation; Deflation Problem; Difficult to Remove; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA CORONARY BALLOON CATHETER TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION WITH 80-90% STENOSIS IN THE DISTAL SAPHENOUS VEIN GRAFT (SVG). THE SVG WAS FEEDING THE DISTAL RIGHT CORONARY ARTERY (RCA) AT THE POSTERIOR DESCENDING ARTERY (PDA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE BALLOON WAS BEING USED TO ATTEMPT FIRST PRE-DILATION. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED, AND THE DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE. MULTIPLE ATTEMPTS WERE MADE TO DEFLATE THE BALLOON, AND THERE WAS PARTIAL DEFLATION. HOWEVER, IT WAS NOT POSSIBLE TO RETRACT THE DEVICE INTO THE GUIDE CATHETER. THE ENTIRE SYSTEM HAD TO BE REMOVED TO REMOVE THE BALLOON. THE BALLOON WAS INFLATED ONCE TO 12 ATM FOR 8 SECONDS. A 2.75X48MM NON-MEDTRONIC STENT WAS PLACED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19826611 ↗

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.