Euphora™ EUP22512XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169559950), received between Jun 16, 2017 and Jun 10, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (2 reports).

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.

• MalfunctionJun 10, 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 MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 100% STENOSIS IN THE MID CIRCUMFLEX (CX) ARTERY. 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. EXCESSIVE FORCE WAS NOT USED. THE BALLOON WAS BEING USED TO PRE-FILL. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED, AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. REMOVAL DIFFICULTIES WERE ALSO REPORTED FOLLOWING INFLATION AS THE BALLOON WOULD NOT DEFLATE. THE DEVICE WAS ABLE TO BE PULLED OUT AS IT WAS SMALL. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19496131 ↗
• MalfunctionJun 16, 2017Deflation Problem; Deflation Problem

  THE PHYSICIAN INTENDED TO USE A EUPHORA BALLOON CATHETER TO TREAT A LESION LOCATED IN THE LAD. NO DAMAGE WAS NOTED TO PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICES FROM THE TRAY/HOOP. THE PHYSICIAN NOTED THAT IT WAS DIFFICULT TO REMOVE THE STYLETTE. THE DEVICES WERE INSPECTED AND PREPPED WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE INDEFLATOR WAS TAKEN OFF THE BALLOON CATHETER AND THE BALLOON WAS DEFLATED WITH A SYRINGE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6646036 ↗

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.