Euphora™ EUP3020XRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169560161), received between Mar 9, 2017 and Mar 12, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2025Deflation Problem; Material Deformation; Deflation Problem; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A EUPHORA RX CORONARY BALLOON, BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. THE DEFLATION DIFFICULTIES WERE NOTED FOLLOWING THE FIRST INFLATION. EVENTUALLY THE ENTIRE SYSTEM, INCLUDING THE WIRE AND THE BALLOON, WERE PULLED THROUGH THE GUIDE. THE LESION HAD TO BE RE-WIRED AND THEN PROCEEDED WITH THE REST OF THE INTERVENTION. THE LESION BEING TREATED WAS A MODERATELY TORTUOUS LESION LOCATED IN THE OSTIUM/PROXIMAL LEFT MAIN (LM) CORONARY ARTERY/LEFT ANTERIOR DESCENDING (LAD) ARTERY/CIRCUMFLEX (CX) ARTERY/OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21585136 ↗
• MalfunctionSep 27, 2024Burst Container or Vessel; Leak/Splash; Deformation Due to Compressive Stress; Burst Container or Vessel; Leak/Splash; Deformation Due to Compressive Stress

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA CORONARY BALLOON CATHETER TO TREAT A LESION. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED DURING BALLOON INFLATION, ON THE FIRST INFLATION. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320339 ↗
• MalfunctionMar 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A LESION. NO DAMAGE WAS NOTED ON THE DEVICE PACKAGING. THERE WERE NO DIFFICULTIES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED DURING DELIVERY. EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE BALLOON CATHETER BROKE DURING ADVANCEMENT THROUGH THE GUIDE CATHETER. RESISTANCE WAS FELT WHEN ATTEMPTING TO DELIVER THE BALLOON CATHETER UP THROUGH THE GUIDE CATHETER, BUT THE DEVICE WAS CONTINUED TO BE PUSHED AND THAT IS WHEN THE BALLOON CATHETER BROKE. THE TUOHY VALVE FELT TOO TIGHT, HOWEVER, IT WAS NOT LOOSENED BEFORE PROCEEDING. THE BALLOON CATHETER BREAK OCCURRED AROUND THE HALF POINT OF THE CATHETER. THE DETACHED PORTION OF THE DEVICE WAS SUCCESSFULLY REMOVED BY BEING BACKED OVER THE WIRE. THE DEVICE NEVER MADE IT OUT OF THE GUIDE CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16642010 ↗
• MalfunctionAug 23, 2021Difficult to Insert; Difficult to Insert

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A EUPHORA BALLOON CATHETER TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. 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 WIRE MOVEMENT ISSUES WERE ENCOUNTERED. IS WAS STATED THAT DIFFICULTIES WERE ENCOUNTERED DURING LOADING OR EXCHANGING GUIDEWIRE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12352687 ↗
• MalfunctionJan 30, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  DURING A PROCEDURE A EUPHORA RX PTCA BALLOON CATHETER WAS USED TO TREAT A NON TORTUOUS, NON CALCIFIED LESION EXHIBITING 85% STENOSIS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT INFLATION DIFFICULTIES WERE ENCOUNTERED. THE BALLOON WAS INFLATED TO 8 ATMS FOR 30 SECONDS AND THE BALLOON FAILED TO FULLY INFLATE FOLLOWING THE FIRST INFLATION. IT WAS ALSO REPORTED THAT DEFLATION ISSUES WERE ALSO ENCOUNTERED WITH THE PARTIALLY INFLATED BALLOON BEING UNABLE TO DEFLATE UPON NEGATIVE PRESSURE BEING APPLIED. THE BALLOON WAS REMOVED FROM THE LESION SITE PARTIALLY INFLATED AND REMOVED FROM PATIENT INTACT THROUGH A MEDTRONIC GUIDE CATHETER. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9646023 ↗
• InjuryApr 10, 2019Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A EUPHORA RX PTCA BALLOON CATHETER TO TREAT MILDLY TORTUOS, MODERATELY CALCIFIED LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS NOT KINKED OR RE-STRAIGHTENED DURING USE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON WAS BEING USED TO PRE-DILATE THE LESION HOWEVER IT COULD NOT BE DEFLATED AT THE LESION SITE AND THEREFORE REMOVAL DIFFICULTIES WERE ENCOUNTERED. WHILE ATTEMPTING TO PULL THE BALLOON WIRE AND CATHETER OUT A DETACHMENT OCCURRED FROM THE BALLOON AT THE BALLOON SHAFT. THE BALLOON PORTION OF THE DEVICE REMAINED IN THE RCA. THE PATIENT WAS SENT TO THE OPERATION ROOM TO HAVE THE REMAINDER OF THE PRODUCT REMOVED SURGICALLY FROM THE RCA. THE PATIENT WAS REPORTED TO BE ALIVE WITH INJURY.

  Patient problems: Injury

  MAUDE report 8498879 ↗
• MalfunctionDec 4, 2018Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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 A BALLOON BURST OCCURRED ON THE FIRST INFLATION. IT IS INDICATED THAT THE BALLOON RUPTURED CIRCUMFERENTIALLY. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8128110 ↗
• MalfunctionOct 22, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ONE EUPHORA RX PTCA BALLOON CATHETER DEVICE WAS REPORTED TO BE DAMAGED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED PRIOR TO ATTEMPT TO DELIVER DEVICE. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND THE DEVICE WAS REMOVED, DUE TO BEING UNABLE TO PROGRESS TOWARDS THE LESION. NO EXCESSIVE FORCE WAS USED. PRODUCT ANALYSIS OF THE RETURNED DEVICE SHOWED A DETACHMENT ON THE HYPOTUBE 57.4CM DISTAL TO THE STRAIN RELIEF. KINKS WERE ALSO EVIDENT ON THE HYPOTUBE AND ON THE DISTAL SHAFT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7990086 ↗
• InjuryOct 17, 2018Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A NON- TORTUOUS AND MILDLY CALCIFIED LESION LOCATED IN THE PROXIMAL RCA. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PREDILATED. 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. BALLOON DEFLATION DIFFICULTIES WERE REPORTED AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. IT WAS NOTED THAT THE DEVICE WAS SLOW TO INFLATE AND ONLY HALF THE BALLOON WAS FILLED WITH CONTRAST. AFTER A 30 SECOND INFLATION THE BALLOON WOULD NOT DEFLATE. PATIENT REPORTED FEELING CHEST DISCOMFORT. THE BALLOON WAS THEN OVERINFLATED TO RUPTURE AND REMOVE. THIS ACTION CAUSED A DISSECTION, WHICH WAS TREATED WITH A STENT. NO OTHER INJURY OCCURRED.

  Patient problems: Chest Pain; Patient Problem/Medical Problem; Vascular Dissection

  MAUDE report 7973646 ↗
• MalfunctionJan 23, 2018Deflation Problem; Deflation Problem

  THE PHYSICIAN WAS ATTEMPTING TO USE A EUPHORA RX BALLOON TO TREAT A NON-CALCIFIED MID LAD LESION. NO DAMAGE WAS NOTED TO DEVICE PACKAGING AND NO ISSUES REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE LESION WAS NOT PRE-DILATED. DURING THE PROCEDURE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING DELIVERY AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT UPON THE FIRST INFLATION, THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. IT WAS NOTICED IMMEDIATELY AND THE PHYSICIAN MANAGED TO WALK THE BALLOON OUT BY DEEP SEATING THE GUIDE CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7211659 ↗
• MalfunctionJul 26, 2017Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A EUPHORA RX BALLOON. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. ISSUES WERE NOTED REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. THE STYLET COULD NOT BE REMOVED FROM THE TIP OF THE DEVICE, THE PHYSICIAN HAD TO PULL EXTREMELY HARD TO REMOVE THE STYLETTE WHICH LODGED IN THEIR GLOVE. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6745667 ↗
• MalfunctionMar 9, 2017Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE ONE EUPHORIA BALLOON CATHETER. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). ABNORMALITIES IN RELATION TO ANATOMY WERE NOTED, THIS WAS A CHRONIC TOTAL OCCLUSION(CTO) PROCEDURE. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING AND NO ISSUES REPORTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND NO ISSUES WERE NOTED. IT WAS REPORTED THAT DURING INITIAL INSERTION, THE BALLOON RUPTURED AND SEPARATED IN THE GUIDE CATHETER. THE PATIENT WAS TREATED WITH A REPLACEMENT MEDTRONIC BALLOON AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6390676 ↗

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.