Euphora™ EUP2012XRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169559882), received between Jul 26, 2017 and Jul 26, 2024 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2024Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA CORONARY BALLOON CATHETER TO TREAT A LESION IN THE OSTIUM LEFT MAIN (LM) CORONARY ARTERY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO THE ANATOMY. IT WAS REPORTED THAT DURING THE PROCEDURE A BALLOON BURST/RUPTURE OCCURRED DURING BALLOON INFLATION AT 10 ATM. A DISSECTION OCCURRED IN THE LEFT MAIN. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 19836511 ↗
• MalfunctionJul 22, 2024Burst Container or Vessel; Inflation Problem; Deformation Due to Compressive Stress; Material Deformation; Burst Container or Vessel; Inflation Problem; Deformation Due to Compressive Stress; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX BALLOON CATHETER TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION WITH 99% STENOSIS LOCATED IN THE DISTAL RIGHT CORONARY (RCA) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE BALLOON WAS BEING USED TO ATTEMPT TO PREDILATE THE LESION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT NOTED WHILE ADVANCING THE DEVICE TO THE LESION. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO THE ANATOMY. IT WAS REPORTED THAT INFLATION DIFFICULTIES WERE ENCOUNTERED. IT WAS ALSO REPORTED THAT A BALLOON BURST/RUPTURE OCCURRED DURING BALLOON INFLATION. IT WAS STATED THAT THE ISSUE WAS NOTED DURING THE SECOND BALLOON INFLATION. THE BALLOON DID NOT INFLATE ON THE FIRST ATTEMPT AND THEN DURING THE SECOND FAILED INFLATION ATTEMPT A RUPTURE WAS SUSPECTED WHEN BLOOD FLASHED BACK INTO THE NON-MEDTRONIC INDEFLATOR UNDER NEGATIVE PRESSURE. THERE WAS ZERO INFLATION OF THE BALLOON. THE DEVICE WAS INSPECTED AFTER THE EVENT AND BLOOD WAS NOTED IN THE BALLOON, SIGNALING A RUPTURE. THE INFLATION DEVICE USED WAS SUCCESSFULLY USED WITH OTHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791484 ↗
• MalfunctionJun 1, 2023Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE TWO EUPHORA RX PTCA BALLOON CATHETERS TO TREAT A LESION. IT WAS REPORTED THAT A BALLOON BURST, LEAK OR CATHETER LEAK OCCURRED IN BOTH DEVICES. IT WAS ALSO NOTED THAT BOTH BALLOON CATHETERS BROKE WHILE BEING DEPLOYED WITHIN A STENT, IN-STENT RESTENOSIS(ISR). NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036510 ↗
• MalfunctionJun 1, 2023Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE TWO EUPHORA RX PTCA BALLOON CATHETERS TO TREAT A LESION. IT WAS REPORTED THAT A BALLOON BURST, LEAK OR CATHETER LEAK OCCURRED IN BOTH DEVICES. IT WAS ALSO NOTED THAT BOTH BALLOON CATHETERS BROKE WHILE BEING DEPLOYED WITHIN A STENT, IN-STENT RESTENOSIS(ISR). NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036478 ↗
• InjuryApr 20, 2023Improper or Incorrect Procedure or Method; Difficult to Open or Remove Packaging Material; Device Dislodged or Dislocated; Device Contamination with Chemical or Other Material; Improper or Incorrect Procedure or Method; Difficult to Open or Remove Packaging Material; Device Dislodged or Dislocated; Device Contamination with Chemical or Other Material

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA BALLOON CATHETER TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THERE WERE ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. IT WAS REPORTED THAT THE PROTECTIVE SHEATH COULD NOT BE REMOVED FROM THE DEVICE. HOWEVER, IT WAS THOUGHT THAT IT WAS A PART OF THE DEVICE. THE BALLOON WAS DELIVERED TO THE LESION WITH THE PROTECTIVE SHEATH STILL ON THE DEVICE. UPON REVIEW, THERE WAS A FOREIGN BODY LEFT BEHIND WHICH WAS TRAPPED TO THE VESSEL WALL WITH A STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Foreign Body In Patient; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16776624 ↗
• MalfunctionNov 16, 2022Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX BALLOON CATHETER TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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 THERE WAS A BALLOON FAILURE, AND THE BALLOON BURST/LEAKED DURING BALLOON INFLATION. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15803402 ↗
• MalfunctionJul 12, 2021Burst Container or Vessel; Inflation Problem; Material Deformation; Burst Container or Vessel; Inflation Problem; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A EUPHORA PTCA BALLOON CATHETER TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION LOCATED IN THE DISTAL DIAGONAL BRANCH. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED. 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 INFLATION DIFFICULTIES WERE ENCOUNTERED AND THE BALLOON BURST DURING THE SECOND INFLATION AT 12 ATM. IT WAS STATED THAT THE CATHETER/DELIVERY SYSTEM WAS DEFORMED AND THAT THE BALLOON CATHETER SEEMED TO HAVE SEVERAL PERFORATION ALONG THE SHAFT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12148744 ↗
• MalfunctionApr 29, 2021Detachment 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 WHEN THE BALLOON WAS BEING REMOVED THERE WAS SOME RESISTANCE AND UPON REMOVAL IT WAS NOTICED THAT THE BALLOON CATHETER TIP WAS MISSING. IT WAS STATED THAT UNDER FLOURO IT WAS FOUND THAT THE BALLOON TIP WAS IN THE CATHETER. THE GUIDE CATHETER AND ALL WIRES WERE REMOVED INCLUDING THE BALLOON TIP. NO FOREIGN OBJECT WAS LEFT IN THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744110 ↗
• 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 10894302 ↗
• InjuryAug 20, 2019Burst Container or Vessel; Burst Container or Vessel

  A EUPHORA RX PTCA BALLOON CATHETER WAS USED TO TREAT A MODERATELY TORTUOUS, NON CALCIFIED LESION EXHIBITING 95% STENOSIS IN THE MID DIAGONAL BRANCH. THE DEVICE WAS NOT INSPECTED. 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. THE LESION WAS PRE DILATED USING THE 2.0 X 12 EUPHORA BALLOON IN THE PROXIMAL DIAGONAL. IT WAS REPORTED THAT THE BALLOON BURST AT 12ATM DURING THE FIRST INFLATION IN THE PROXIMAL DIAGONAL RESULTING IN A LOCALIZED DISSECTION IN THE PROXIMAL AND MID VESSEL. AN ATTEMPT WAS MADE TO PASS A 2.0 X 12MM RESOLUTE DRUG ELUTING STENT BUT THIS WAS UNSUCCESSFUL. AN NON MEDTRONIC 2.0 X 8MM BALLOON WAS SUCCESSFULLY PASSED INTO THE MID DIAGONAL AND SUCCESSFULLY DEPLOYED AT 8 ATM. A 2.0 X 8MM RESOLUTE DRUG ELUTING STENT WAS DEPLOYED INTO THE PROXIMAL DIAGONAL AT 12 ATM WHICH SUCCESSFULLY RESOLVED THE LOCALIZED DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 8910577 ↗
• InjuryJul 30, 2018Burst Container or Vessel; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT A EUHPORA RX BALLOON CATHETER WAS ATTEMPTED TO BE USED TO PRE-DILATE A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION IN THE MID RCA. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED USING A 1.25X12 MM SPRINTER LEGEND BALLOON. THE EUPHORA DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. IT IS REPORTED THAT THE EUPHORA DEVICE WAS ADVANCED AND WHEN INFLATED ABOVE RATED BURST PRESSURE (16 ATMS) THE BALLOON BURST. THE EUPHORA BALLOON WAS USED FOR SEVERAL INFLATIONS IN THE LESION AREA. IT BURST ON THE LAST INFLATION. A SUDDEN DROP IN PRESSURE NOTED ON THE INFLATION DEVICE. A DISSECTION WAS NOTED AT THE BALLOON BURST SITE. A 2.5X12 MM EUPHORA DEVICE WAS THEN DELIVERED AND INFLATED FOR 1 MINUTE. THERE WAS AN ANGIOGRAPHICAL IMPROVEMENT AND IT WAS CONFIRMED THAT THERE WAS NO PERFORATION. NO FURTHER PATIENT COMPLICATIONS REPORTED FOR THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 7731101 ↗
• MalfunctionJun 7, 2018Burst Container or Vessel; Burst Container or Vessel

  ONE EUPHORA RX PTCA BALLOON CATHETER WAS ATTEMPTED TO BE USED TO PRE-DILATE A MILDLY TORTUOUS, MILDLY CALCIFIED LESION IN THE MID LAD. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. THE BALLOON WAS BEING USED TO PRE-DILATE. IT WAS REPORTED THAT THE BALLOON RUPTURED DURING THE FIRST INFLATION, 3-5 ATM'S OF PRESSURE HAD BEEN APPLIED. THERE WAS A SUDDEN DROP IN PRESSURE. THE DEVICE WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED USING A NON-MEDTRONIC DEVICE. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7577017 ↗
• 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 6746329 ↗
• MalfunctionJul 26, 2017Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  THE PHYSICIAN WAS INTENDING ON USING A EUPHORA RX BALLOON IN THE PATIENT. NO DAMAGE WAS NOTED TO THE PACKAGING NOR WERE THERE ANY ISSUES NOTED WHEN REMOVING THE DEVICE FORM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES AND NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE WAS NOT FLUSHED IN THE HOOP. THE DEVICE WAS NOT PLACED IN A BOWL OF SALINE TO ACTIVATE THE HYDROPHILIC COATING. THE PACKAGE WAS OPENED BY THE NURSE AND REMOVED BY THE TECH. THE TECH THEN ATTEMPTED TO REMOVE THE STYLET TO PREP THE BALLOON. IT IS REPORTED THAT IT TORE BOTH THE TECHS GLOVES AND PHYSICIANS GLOVES TRYING TO GET THE STYLET OUT. DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6745549 ↗
• 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 DEVICE PACKAGING AND NO ISSUES REMOVING THE DEVICE FROM THE HOOP. IT WAS REPORTED THAT ISSUES WERE NOTED DURING INSPECTION. THE STYLET COULD NOT BE REMOVED FROM THE BALLOON AND IT TORE THE PHYSICIANS GLOVE DURING THE ATTEMPT. THE DEVICE WAS FLUSHED IN THE HOOP TO ACTIVATE THE HYDROPHILIC COATING PRIOR TO ATTEMPTING TO REMOVE PROTECTIVE STYLET. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6743993 ↗

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.