Euphora™ EUP2530XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169560055), received between May 10, 2019 and Jun 1, 2023 — classified as 1 injury, 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. 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.

• InjuryJun 1, 2023Burst Container or Vessel; Detachment of Device or Device Component; Device Dislodged or Dislocated; Burst Container or Vessel; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% 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 NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT A BALLOON BURST OCCURRED DURING THE SECOND INFLATION AT 15 ATM. IT WAS DETAILED THAT PART OF THE BALLOON AND MARKER-BAND DETACHED FROM THE BALLOON SHAFT AND REMAINED IN THE TARGET VESSEL. THE DETACHED PORTION OF THE BALLOON WAS REMOVED USING A TELESCOPE AND ONE 1.5X15MM EUPHORA BALLOON. THE DISTAL BALLOON MARKER WAS INITIALLY REMOVED BUT IT BECAME LOOSE AFTER REMOVING THE TELESCOPE AND FRACTURED BALLOON THE BALLOON MARKER WAS INJECTED BACK INTO A SMALL PROXIMAL SIDE BRANCH OF THE CIRCUM FLEX USING A CONTRAST INJECTION. IT WAS DECIDED TO LEAVE THE BALLOON MARKER IN THE SIDE BRANCH AS THERE WAS NO SAFE WAY TO REMOVE IT FROM THE VES

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 17036495 ↗
• MalfunctionMay 10, 2019Leak/Splash; Leak/Splash

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE AN EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MILDLY TORTUOUS AND CALCIFIED LESION EXHIBITING 80% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. 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 DURING DELIVERY. IT WAS REPORTED THAT FOLLOWING INFLATION OF THE BALLOON AT 10ATM THAT THE BALLOON LOST PRESSURE SLOWLY. WHEN INSPECTED OUTSIDE THE BODY A SMALL PIN HOLE WAS OBSERVED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8599115 ↗

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.