Euphora™ EUP2520XRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169560031), received between Jul 11, 2017 and Feb 3, 2026 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Deflation Problem; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA RX CORONARY BALLOON, DEFLATION DIFFICULTIES WERE ENCOUNTERED IN THE PR OXIMAL DIAGONAL BRANCH ARTERY WHICH EXHIBITED MILD TORTUOSITY, MODERATE CALCIFICATION AND 90% STENOSIS. AN ADDITIONAL SYRINGE WAS ATTEMPTED TO BE USED FOR NEGATIVE PRESSURE BUT WAS NOT SUCCESSFUL AND THE BALLOON REMAINED INFLATED. THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE, AND THE BALLOON REMAINED INFLATED IN THE ARTERY BEFORE BEING REMOVED FROM THE BODY IN AN INFLATED STATE. THE CASE TIMING WAS DELAYED DUE TO THE REMOVAL OF THE BALLOON AND WIRES. THE DEVICE WAS INSPECTED PRIOR TO USE AND 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 PROCEDURE WAS ULTIMATELY FOLLOWED BY A SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245016 ↗
• MalfunctionJun 6, 2025Inflation Problem; Leak/Splash; Device Damaged by Another Device; Material Deformation; Material Split, Cut or Torn; Inflation Problem; Leak/Splash; Device Damaged by Another Device; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT A BALLOON LEAK OCCURRED ON ONE EUPHORA CORONARY BALLOON CATHETER. THE DEVICE WAS BEING USED IN A NON-TORTUOUS LESION IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS BEING USED TO PRE-DILATE THE LESION. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED PRIOR TO INSERTION INTO PATIENT WITH NO ISSUES. THE BALLOON WAS THEN INSERTED INTO THE PATIENT AND ONCE THE BALLOON PRESENTED OUTSIDE THE 6F LAUNCHER GUIDE CATHETER IT WAS NOTICED THAT THE BALLOON LOOKED DIFFERENT, AND WAS 'SHREDDED' IN APPEARANCE, BUT PROCEEDED TO THE LESION. THERE WAS NO RESISTANCE NOTED WHEN INSERTING THE BALLOON INSIDE THE LAUNCHER GUIDE CATHETER. OTHER ACCESSORY DEVICES WERE NOT INSIDE THE LAUNCHER DEVICE WHEN THE BALLOON WAS BEING ADVANCED. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON INSIDE THE PATIENT TO 12 ATM, BUT THE BALLOON WOULD NOT HOLD. THERE WERE INFLATION DIFFICULTIES. A BURST DID NOT OCCUR. THE ISSUE OCCURRED ON THE FIRST ATTEMPTED INFLATION. THE DEVICE WAS NOT MOVED OR REPOSITIONED WHILE INFLATED. A SALINE AND CONTRAST SOLUTION WAS USED. THE BALLOON WAS REMOVED WITHOUT ISSUES. IT IS NOT BELIEVED THAT THE LAUNCHER CAUSED OR CONTRIBUTED TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157039 ↗
• InjuryJul 26, 2024Deflation Problem; Material Deformation; Deflation Problem; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA CORONARY BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 70% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED, AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE WITH THE INDEFLATOR. THE DEFLATION ISSUES OCCURRED FOLLOWING THE FIRST INFLATION. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON WITH A 20CC SYRINGE WITHOUT SUCCESS. THE BALLOON WAS ABLE TO BE PULLED BACK WITHOUT ANY ISSUE DUE TO THE UNDERSIZE OF THE BALLOON AND VESSEL. THE ENTIRE SYSTEM WAS PULLED OUT, INCLUDING THE LAUNCHER GUIDE CATHETER. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19837533 ↗
• MalfunctionSep 20, 2023Entrapment of Device; Detachment of Device or Device Component; Material Deformation; Entrapment of Device; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, NON CALCIFIED LESION WITH 75% STENOSIS IN THE PROXIMAL CIRCUMFLEX (CX) 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. IT WAS REPORTED THAT THE DEVICE WAS DEFORMED DURING REMOVAL. IT WAS DETAILED THAT THE BALLOON COLLAPSED ON ITSELF UPON REMOVAL. THERE WERE NO DEFLATION DIFFICULTIES, DEVICE DETACHMENT OR A LEAK/BURST. THERE WAS NO RESISTANCE NOTED DURING WITHDRAWAL OF THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. THE BALLOON WAS FULLY DEFLATED WHEN ATTEMPTED TO REMOVE. THE DEVICE WAS ATTEMPTED TO BE INFLATED WITH NO DIFFICULTIES ENCOUNTERED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778947 ↗
• InjuryDec 5, 2022Deflation Problem; Deflation Problem

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER. IT WAS REPORTED THAT THE BALLOON MALFUNCTIONED AND DEFLATION DIFFICULTIES WERE ENCOUNTERED. IT WAS DETAILED THAT THE BALLOON WAS LEFT IN THE INFLATED POSITION AND IT WAS UNABLE TO BE DEFLATED. MULTIPLE ATTEMPTS WERE MADE TO SUCK THE NEGATIVE PRESSURE, HOWEVER, ALL WERE UNSUCCESSFUL IN DEFLATING THE DEVICE. A STIFF CORONARY WIRE WAS TAKEN THROUGH THE GUIDE CATHETER IN AN ATTEMPT TO PIERCE THE PROXIMAL PORTION OF THE BALLOON. THE PATIENT'S BLOOD PRESSURE BECAME UNSTABLE. THE GUIDE CATHETER WAS ADVANCE OVER THE PROXIMAL PORTION OF THE BALLOON AND WITH GENTLE NEGATIVE FORCE THE BALLOON AND THE GUIDEWIRE WERE RETRACTED AS ONE UNIT DOWN THE AORTA. THE BALLOON AND GUIDE CATHETER WERE REMOVED OUT THROUGH THE RIGHT FEMORAL SHEATH. NO FURTHER INJURY WAS REPORTED.

  Patient problems: High Blood Pressure/ Hypertension; Insufficient Information; Low Blood Pressure/ Hypotension

  MAUDE report 15913323 ↗
• InjuryNov 15, 2022Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A LESION. IT WAS REPORTED THAT DEFLATION DIFFICULTIES OCCURRED. THE BALLOON REMAINED INFLATED INSIDE THE PATIENT'S BODY AND FELL OFF THE SHAFT. SEVERAL ATTEMPTS WERE MADE TO POKE THE BALLOON USING VARIOUS TOOLS IN ORDER TO DEFLATE THE BALLOON, BUT WERE UNSUCCESSFUL. EVENTUALLY, IT WAS POSSIBLE TO LODGE THE BALLOON IN A NON-MEDTRONIC GUIDE EXTENSION CATHETER AND PULL THE BALLOON OUT OF THE BODY. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15795868 ↗
• MalfunctionAug 3, 2022Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION 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 PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT A BALLOON BURST / RUPTURE OCCURRED DURING THE FIRST BALLOON INFLATION. IT WAS STATED THAT THE BALLOON WAS PULLED BACK INTO THE GUIDE BUT IT WAS UNABLE TO BE REMOVED FROM THE GUIDE. BOTH THE GUIDE CATHETER AND THE BALLOON WERE REMOVED TOGETHER SAFELY FROMTHE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156049 ↗
• InjuryJul 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A LESION. IT WAS REPORTED THAT A BALLOON DETACHMENT OCCURRED. THE DETACHED BALLOON DOES NOT REMAIN IN THE PATIENT. IT WAS STATED THAT THE BALLOON SNAPPED OFF THE CATHETER AND A SNARE DEVICE WAS USED TO RETAIN THE BALLOON. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15026010 ↗
• MalfunctionMay 20, 2021Deflation Problem; Deflation Problem

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A LESION LOCATED IN THE MID CIRCUMFLEX (CX) 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. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED AND THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. IT WAS STATED THAT THE BALLOON WAS REMOVED FROM THE PATIENT WHILE STILL INFLATED. IT WAS STATED THAT THE PROCEDURE WAS COMPLETED BY PLACING A STENT AND POST DILATING USING A NC BALLOON. THERE WAS NO PATIENT IMPACT AND THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854135 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, FOUR RESOLUTE ONYX DES WERE IMPLANTED IN THE CIRCUMFLEX. TWO EUPHORA PTCA BALLOON WERE ALSO USED. APPROXIMATELY 1 DAY POST INDEX PROCEDURE, PATIENT SUFFERED FROM ELEVATED CARDIAC ENZYMES. INVESTIGATOR ASSESSED THAT THE EVENT WAS PROBABLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED. THE CEC ADJUDICATED THAT A MI OCCURRED IN THE TARGET VESSEL, THE CX.

  Patient problems: Myocardial Infarction

  MAUDE report 10894216 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 2 RESOLUTE ONYX WERE IMPLANTED IN THE RCA. TWO EUPHORA AND ONE NC EUPHORA PTCA BALLOONS WERE ALSO USED DURING THE INDEX PROCEDURE. APPROXIMATELY ONE DAY POST INDEX PROCEDURE, PATIENT'S CARDIO BIOMARKER WERE ELEVATED. CEC ADJUDICATED THE EVENT AS TARGET VESSEL MI INVOLVING THE RCA. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO ANTIPLATELET MEDICATION BUT POSSIBLY RELATED TO INDEX DEVICE. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 10885376 ↗
• MalfunctionSep 5, 2019Deflation Problem; Deflation Problem

  A EUPHORA RX PTCA BALLOON CATHETER WAS USED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8964290 ↗
• MalfunctionDec 13, 2018Deflation Problem; Material Deformation; Deflation Problem; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 85% STENOSIS LOCATED IN THE MID RCA. 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE FOLLOWING THE FIRST INFLATION. THE BALLOON WAS REMOVED THROUGH THE GUIDE CATHETER. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8159143 ↗
• InjuryJul 11, 2017Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  THE PHYSICIAN INTENDED TO USE EUPHORA RX BALLOON CATHETER TO TREAT A LESION IN THE LCX. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THERE WAS SOME DIFFICULTY EXPERIENCED WHEN REMOVING THE PROTECTIVE SHEATH/PACKAGING STYLETTE FROM THE DEVICE BUT THE STYLETTE WAS REMOVED. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE USED DURING DELIVERY. NO DIFFICULTIES WERE NOTED DURING INFLATION OF THE DEVICE. IT WAS REPORTED THAT THERE WERE BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. 50%/50% CONCENTRATION OF CONTRAST/SALINE WERE USED BY THE PHYSICIAN. THE ISSUE OCCURRED ON THE FIRST INFLATION. THE PHYSICIAN INFLATED THE BALLOON TO 23 ATM TO BURST THE BALLOON SO THEY COULD REMOVE IT. THE RUPTURED BALLOON CAUSED A DISSECTION WHICH WAS TREATED WITH TWO STENTS. THE PHYSICIAN COMPLETED THE PROCEDURE WITH EUPHORA 2.5 X 20 RX (212633097). THE PHYSICIAN STATED THAT THE LESION WAS HEAVILY CALC

  Patient problems: Intimal Dissection; Patient Problem/Medical Problem

  MAUDE report 6700134 ↗

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.