Euphora™ EUP1512XRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169559837), received between Jul 27, 2017 and May 26, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Entrapment of Device; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA RX CORONARY BALLOON CATHETER, DIFFICULTIES WERE ENCOUNTERED WHEN REMOVING THE BALLOON OFF THE GUIDEWIRE FOLLOWING BALLOON INFLATION. THE INFLATION PRESSURE APPLIED TO THE BALLOON PRIOR TO DIFFICULTIES WAS NOMINAL. THERE WAS NO ISSUE DURING DELIVERY OF THE GUIDEWIRE TO/ACROSS THE LESION SITE. THE DIFFICULTY OCCURRED DURING POST INFLATION OF THE BALLOON. THE BALLOON WAS USED THREE TIMES AND AFTER USE, IT BECAME HUNG UP ON THE WIRE WHEN ATTEMPTING REMOVAL. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED DURING DELIVERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25276934 ↗
• MalfunctionMar 24, 2026Burst Container or Vessel; Improper or Incorrect Procedure or Method

  DURING A PROCEDURE INVOLVING ONE EUPHORA RX BALLOON CATHETER A BALLOON BURST/RUPTURE OCCURRED DURING BALLOON INFLATION. IT WAS NOTED THAT THE BALLOON WAS NOT OVER INFLATED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673276 ↗
• InjuryMar 24, 2026Burst Container or Vessel; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ONE EUPHORA RX CORONARY BALLOON AND ONE 2.0 X 15 MM ONYX DRUG ELUTING STENT WERE USED. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE CIRCUMFLEX (CX) AND OBTUSE MARGINAL (OM) WHICH EXHIBITED NO TORTUOSITY AND NO CALCIFICATION. 30-40% LESION STENOSIS WAS PRESENT IN THE OSTIAL CX AND 80% LESION STENOSIS WAS PRESENT IN THE OM. NO ISSUES WERE NOTED ON THE DEVICES PRIOR TO USE. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH THE EUPHORA BALLOON WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHILE ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE BALLOON BURST WHEN INFLATED TO NOMINAL PRESSURE. AFTER REMOVAL OF THE BALLOON, IMAGING WAS PERFORMED TO ASSESS THE VESSEL AND CONTRAST DYE STATUS, WHICH INITIALLY MADE THE VESSEL APPEAR TO BE DISSECTED. THE PHYSICIAN TOOK ANOTHER PICTURE AFTER BALLOON REMOVAL, AND THE CONTRAST DYE WAS GONE. THE BALLOON WAS EVALUATED OUTSIDE THE BODY AND DEMONSTRATED A RUPTURED BALLOON. THE ONYX DEVICE FAILED TO CROSS THE LESION. THE PATIENT WAS ASYMPTOMATIC AND THERE APPEARED TO BE NO EXTRAVASATION. BEDSIDE ECHO REVEALED NO PERICARDIAL EFFUSION. GIVEN THE PATIE

  Patient problems: Vascular Dissection

  MAUDE report 24673197 ↗
• MalfunctionNov 1, 2024Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE TWO EUPHORA RX PTCA BALLOON CATHETERS TO TREAT A LESION. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICES WERE BEING USED TO PRE-DILATE THE LESION. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE BALLOONS RUPTURED DURING BALLOON INFLATION, DURING AN ANGIOPLASTY ATTEMPT. THE DEVICES WERE NOT MOVED OR REPOSITIONED WHILE INFLATED. THE DEVICES WERE REMOVED WITH NO ISSUES. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586375 ↗
• MalfunctionSep 30, 2024Burst Container or Vessel; Material Deformation; Burst Container or Vessel; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A LESION. IT WAS REPORTED THAT THE BALLOON RUPTURED WHEN INFLATED DURING ANGIOPLASTY ATTEMPT. THE DEVICE WAS REMOVED WITH NO ISSUES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20331594 ↗
• MalfunctionMar 25, 2024Burst Container or Vessel; Leak/Splash; Material Deformation; Material Split, Cut or Torn; Burst Container or Vessel; Leak/Splash; Material Deformation; Material Split, Cut or Torn

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA CORONARY BALLOON CATHETER TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 100% CHRONIC TOTAL OCCLUSION (CTO) IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON BURST UPON ATTEMPTED INFLATION AND DILATION OF THE LESION. NO ADVERSE EFFECT TO THE PATIENT WERE REPORTED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968865 ↗
• MalfunctionJun 20, 2023Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX BALLOON CATHETER DURING HEART CATHETERIZATION. IT WAS REPORTED THAT THE ARTERY BALLOON RUPTURED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17166478 ↗
• MalfunctionNov 29, 2022Fracture; Leak/Splash; Detachment of Device or Device Component; Fracture; Leak/Splash; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX CORONARY BALLOON CATHETER AND ONE LAUNCHER GUIDE CATHETER TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE DIAGONAL BRANCH. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED ON THE EUPHORA WITH NO ISSUES NOTED. THE LAUNCHER WAS PREPPED PER IFU WITH NO ISSUES. THE EUPHORA DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING THE DELIVERY. IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE, AND THAT A BALLOON LEAK OCCURRED DURING ATTEMPTED INFLATION. WHEN THE BALLOON WAS REMOVED FROM THE LAUNCHER GUIDE CATHETER IT WAS NOTICED THAT THE SHAFT WAS FRACTURED. IT WAS ALSO NOTED THAT THERE WAS A COMPRESSION/FLATTENING OF THE LAUNCHER GUIDE CATHETER. THE DETACHED PORTION OF THE DEVICE DOES NOT REMAIN IN THE PATIENT. ALL PIECES OF THE DEVICE WERE SAFELY REMOVED WITH A NORMAL REMOVAL METHOD. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876824 ↗
• MalfunctionJul 24, 2018Burst Container or Vessel

  A EUPHORA BALLOON CATHETER WAS INTENDED TO BE USED TO PRE-DILATE A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. 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 A BALLOON BURST OCCURRED DURING THE FIRST BALLOON INFLATION. THERE WAS A SUDDEN DROP IN PRESSURE. THE DEVICE WAS NOT MOVED OR REPOSITIONED PRIOR TO THE BURST. THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7713309 ↗
• MalfunctionJul 16, 2018Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  A EUPHORA BALLOON CATHETER BURST DURING INFLATION IN A HEAVILY CALCIFIED LESION. THE BALLOON WAS REMOVED INTACT WITH NO CONSEQUENCES TO THE PATIENT OR OTHERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7689955 ↗
• MalfunctionJul 27, 2017Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  TWO EUPHORA BALLOON DILATION CATHETERS WERE ATTEMPTED TO BE PREPPED FOR USE. THE DEVICES WERE BOTH REMOVED FROM PACKAGING AND HOOP WITH NO ISSUES NOTED. THEY WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICES WERE NOT PLACED IN SALINE SOLUTION PRIOR TO ATTEMPTED REMOVAL OF THE STYLETTE. SHEATH COULD NOT BE REMOVED. IT IS REPORTED THAT THE STYLETTE WOULD NOT COME OUT OF THE BALLOONS. THE PHYSICIAN AND THE TECH BOTH TRIED WITH THEIR HANDS AND HEMOSTATS. STYLETTE WOULD NOT COME OUT. IT ALSO TORE THEIR GLOVES WITH NO INJURY TO THEM. THE DEVICES WERE NOT USED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6746292 ↗

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.