Euphora™ EUP2506XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169559998), received between Apr 25, 2017 and Nov 23, 2020 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 2 RESOLUTE ONYX WERE IMPLANTED IN THE RCA. TWO EUPHORA AND ONE NC EUPHORA PTCA BALLOONS WERE ALSO USED DURING THE INDEX PROCEDURE. APPROXIMATELY ONE DAY POST INDEX PROCEDURE, PATIENT'S CARDIO BIOMARKER WERE ELEVATED. CEC ADJUDICATED THE EVENT AS TARGET VESSEL MI INVOLVING THE RCA. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO ANTIPLATELET MEDICATION BUT POSSIBLY RELATED TO INDEX DEVICE. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 10885596 ↗
• MalfunctionApr 25, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A EUPHORA RX BALLOON TO TREAT A MODERATELY CALCIFIED AND TORTUOUS MID CX LESION EXHIBITING 90% STENOSIS. NO DAMAGE WAS NOTED TO DEVICE PACKAGING. NO ISSUES REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. DIFFICULTY WAS ENCOUNTERED REMOVING THE STYLETTE FROM THE TIP. IT WAS REPORTED THAT IT WOULD ONLY COME OUT 2-3CM. THE TECH PUSHED THE STYLETTE BACK IN AND TWISTED AND WAS ABLE TO REMOVE THE STYLETTE. FORCE WAS REQUIRED TO REMOVE IT. DEVICE WAS FLUSHED IN THE HOOP. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE USED. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING INFLATION. 60 %SALINE/40 %CONTRAST WAS USED. IT WAS REPORTED THAT AFTER THE 1ST INFLATION, THE BALLOON FAILED TO DEFLATE AND THE PHYSICIAN HAD TO PULL THE BALLOON BACK INTO THE GUIDE AND OUT. THE DEVICE WAS NOT MOVED OR REPOSITIONED PRIOR TO THE DEFLATION DIFFICULTIES. A NEW EUPHORA WAS USED TO PROGRESS THE CASE FOLLOWED BY STENT PLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6518169 ↗

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.