Euphora™ EUP27520XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169560109), received between Jul 23, 2018 and Jul 23, 2018 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

2. Jul 13, 2017Terminated

   Stylette removal difficulties on the Euphora and Solarice products.

   Z-3136-2017 · Root cause: Process design · Recall details · 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 23, 2018Burst Container or Vessel; Leak/Splash; Decrease in Pressure; Leak/Splash

  A EUPHORA RX BALLOON CATHETER WAS INTENDED TO BE USED TO PRE-DILATE A MODERATELY TORTUOUS, SEVERELY CALCIFIED, ECCENTRIC LESION WITH 85% STENOSIS IN THE MID RCA. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE BALLOON BURST ON THE FIRST INFLATION AFTER 12 ATM OF PRESSURE HAD BEEN APPLIED. THE DEVICE WAS NOT MOVED OR REPOSITIONED PRIOR TO THE BURST. IMMEDIATE ANGIOGRAPHY REVEALED CONTRAST IN THE CORONARY ARTERY. LOW PRESSURE WAS NOTED. THERE WAS AN ATTEMPT TO RE-INFLATE THE BALLOON FURTHER. THE LESION WAS THOUGHT TO BE SUFFICIENTLY DILATED, AND THE PROCEDUREWAS COMPLETED WITH A RESOLUTE ONYX STENT. NO PATIENT INJURY IS REPORTED.

  Patient problems: Calcium Deposits/Calcification; No Consequences Or Impact To Patient; Stenosis

  MAUDE report 7710753 ↗

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.