Euphora™ EUP3515XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169560284), received between Feb 16, 2023 and Mar 28, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Burst Container or Vessel; Deflation Problem; Inflation Problem; Difficult to Remove; Material Deformation; Burst Container or Vessel; Deflation Problem; Inflation Problem; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA RX CORONARY BALLOON CATHETER, BALLOON DEFLATION DIFFICULTIES OCCURRED. THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. IT WAS ALSO REPORTED THAT THERE WERE DIFFICULTIES REMOVING THE BALLOON FOLLOWING BALLOON INFLATION. THE DEFLATION DIFFICULTIES WERE NOTED FOLLOWING THE FIRST INFLATION AT 8 ATM. ATTEMPTS WERE MADE TO DEFLATE THE BALLOON BY PULLING NEGATIVE USING BOTH AN INSUFFLATOR AND A 20ML SYRINGE TO NO AVAIL. THE DEVICE WAS PULLED OUT OF THE VESSEL AND THROUGH THE BODY TO THE SHEATH IN THE RIGHT ARM WHERE THE BALLOON APPEARED TO BURST. THE DEVICE WAS THEN ABLE TO BE REMOVED THROUGH THE SHEATH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718028 ↗
• InjuryFeb 16, 2023Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). 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. 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 FIRST BALLOON INFLATION AT NOMINAL 8 ATM. IT WAS ALSO REPORTED THAT DURING REMOVAL OF THE DEVICE A BALLOON DETACHMENT OCCURRED. REMOVAL DIFFICULTIES WERE ENCOUNTERED WHEN ATTEMPTING TO REMOVE THE DETACHED PORTION FROM THE PATIENT. THE DETACHED PORTION OF THE DEVICE REMAINS IN THE PATIENT. THE PATIENT IS GOING FOR OPEN HEART SURGERY DUE TO THE BALLOON RUPTURE, TO REMOVE A PIECE OF THE BALLOON LEFT IN THE RCA. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 16387906 ↗

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.