Euphora™ EUP3512XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169560277), received between Apr 21, 2023 and Sep 15, 2025 — classified as 2 deaths, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathSep 15, 2025Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA CORONARY BALLOON CATHETER, BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE BALLOON WAS DELIVERED AND INFLATED WITHOUT ISSUE. THE BALLOON WAS UNABLE TO DEFLATE AT THE LESION SITE. THE BALLOON WAS INTENTIONALLY RUPTURED AND THEN IT WAS ATTEMPTED TO REMOVE IT. THE INFLATION PRESSURE APPLIED WAS 20 ATM. THE BALLOON SHAFT FRACTURED AND WAS REMOVED IN TWO PIECES. IT WAS NOTED THAT THERE WAS NO KINKING OF THE SHAFT WHEN THE BALLOON WAS BEING ADVANCED. THE ISSUE OCCURRED ON FIRST INFLATION. THE LESION BEING TREATED WAS SEVERELY TORTUOUS LOCATED IN THE OSTIUM/PROXIMAL LEFT MAIN (LM) CORONARY ARTERY/ LEFT ANTERIOR DESCENDING (LAD) ARTERY/ CIRCUMFLEX (CX) ARTERY. THE PATIENT SUFFERED CARDIAC ARREST REQUIRING PLACEMENT OF TWO NON-MEDTRONIC HEART PUMPS. THE PATIENT SUBSEQUENTLY DIED.

  Patient problems: Cardiac Arrest

  MAUDE report 23050680 ↗
• DeathMay 16, 2025Deflation Problem; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A EUPHORA BALLOON RX, THE DEVICE BECAME STUCK IN THE INFLATED POSITION WITHIN THE LEFT MAIN TO CIRCUMFLEX ARTERY. THE COMPLICATION AROSE DURING FINAL POST-DILATATION OF STENTS IN THE LEFT MAIN CORONARY ARTERY EXTENDING INTO THE LEFT CIRCUMFLEX ARTERY, WHEN A 3.5X15 MM NON-MEDTRONIC NC BALLOON FRACTURED. THE DISTAL (MONORAIL) OPAQUE TIP SEPARATED FROM THE HYPOTUBE AND REMAINED WITHIN THE CORONARY ARTERY, STUCK IN THE PREVIOUSLY IMPLANTED STENT IN THE LEFT MAIN TO THE CIRCUMFLEX ARTERY. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE FRACTURED NON-MEDTRONIC BALLOON. DURING EFFORTS TO RETRIEVE THE NON-MEDTRONIC DEVICE, A EUPHORA BALLOON RX WAS INTRODUCED AND SUBSEQUENTLY BECAME STUCK IN THE SAME SEGMENT, ALSO IN THE INFLATED POSITION. AN ATTEMPT WAS MADE TO DEFLATE THE EUPHORA BALLOON BY CUTTING THE SHAFT, BUT THIS WAS UNSUCCESSFUL. SEVERAL ADDITIONAL RETRIEVAL EFFORTS FAILED. THE PATIENT WAS ULTIMATELY REFERRED FOR SURGICAL INTERVENTION FOR POTENTIAL DEVICE RETRIEVAL AND CORONARY ARTERY BYPASS GRAFTING (CABG).

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

  MAUDE report 22037070 ↗
• MalfunctionApr 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE DETACHED, CRACKED OR FRACTURED AT THE CATHETER DURING REMOVAL. THE DETACHED PART OF THE CATHETER WAS PULLED OUT AND DOES NOT REMAIN IN THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16786990 ↗

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.