Euphora™ EUP2015XRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169559899), received between Jul 4, 2017 and Nov 19, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2024Deflation Problem; Entrapment of Device; Difficult to Remove; Improper or Incorrect Procedure or Method; Material Deformation; Deflation Problem; Entrapment of Device; Difficult to Remove; Improper or Incorrect Procedure or Method; Material Deformation

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE ONE EUPHORA CORONARY BALLOON CATHETER AND DIFFICULTIES WITH DEFLATION OF THE BALLOON OCCURRED, WITH THE DEVICE BEING SLOW TO DEFLATE AT THE LESION SITE. ADDITIONALLY, THE BALLOON WAS INFLATED TO 14-16 ATM AND STUCK TO THE WIRE AT THE RAPID EXCHANGE PORT. THE CATHETER STRETCHED OUT AND DEFORMED. THE SHAFT WAS COMPROMISED AND DISINTEGRATED BUT DID NOT SEPARATE INTO TWO PIECES. THE DEVICE WAS BEING USED IN A CHRONIC TOTAL OCCLUSION. IT WAS POSSIBLE TO REMOVE THE WHOLE SYSTEM FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723858 ↗
• MalfunctionSep 10, 2024Entrapment of Device; Inflation Problem; Difficult to Insert; Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn; Entrapment of Device; Inflation Problem; Difficult to Insert; Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA CORONARY BALLOON CATHETER TO TREAT A NON-TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS IN THE DISTAL LEFT MAIN (LM) CORONARY ARTERY. THE LM LESION WENT INTO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. A 7F LAUNCHER GUIDE CATHETER AND A 7F NON-MEDTRONIC (MDT) GUIDE EXTENSION CATHETER (GEC) WAS BEING USED. THERE WERE TWO WIRES BEING USED, ONE DOWN THE LAD AND ONE THE CIRCUMFLEX (CX) ARTERY. RESISTANCE WAS FELT WHEN ADVANCING THE EUPHORA BALLOON IN THE NON-MDT GEC, OVER THE NON-MDT WIRE. A NON-MDT BALLOON WAS OVER THE OTHER WIRE. TOWELS WERE PLACED OVER THE WIRES TO KEEP THEM SEPARATED. IT WAS NOT POSSIBLE TO INFLATE THE EUPHORA DEVICE BECAUSE RESISTANCE WAS FELT, AND IT IS BELIEVED THAT THE WIRE GOT WRAPPED AROUND THE EUPHORA BALLOON CATHETER. WHEN AN ATTEMPT WAS MADE TO PULL OUT THE DEVICE THE SHAFT BROKE. IT WAS POSS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20178984 ↗
• MalfunctionJan 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX BALLOON CATHETER TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NO ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE DEVICE DETACHED INTO TWO SEPARATE PIECES. THE BALLOON WAS INSERTED INTO THE GUIDE CATHETER WHEN NEGATIVE PREP WAS PERFORMED. UPON PULLING NEGATIVE, BLOOD WAS INSTANTLY NOTED IN THE INDELFLATOR. THE BALLOON WAS NEVER FULLY ADVANCED INTO THE PATIENT'S BODY, IT WAS NOT ADVANCE PAST THE GUIDE CATHETER TIP DUE TO REALIZING THERE WAS AN ISSUE DURING NEGATIVE PREP ON THE BALLOON. DURING REMOVAL OF THE DEVICE, THE CATHETER OF THE DEVICE DETACHED. THE DETACHED OCCURRED AFTER THE GUIDE HUB, INSIDE THE GUIDE CATHETER. THE GUIDE CATHETER WAS COMPLETED REMOVED FROM PATIENT. IT WAS THEN FLUSHED AND THE REST OF THE EUPHORA DEVICE WAS RETRIEVED. THE BALLOON WAS NEVER INFLATED, ONLY PULLED NEGATIVE FOR PREP. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245292 ↗
• MalfunctionMar 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE A EUPHORA RX CORONARY BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, NON CALCIFIED LESION WITH 80% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION.THE GUIDE WIRE WAS THEN PULLED OUT OF THE BODY TO RE-SHAPE BEFORE RE-INSERTING, IN AN ATTEMPT TO NOT HAVE THE GUIDE WIRE GO THROUGH THE STRUT OF A PREVIOUSLY PLACED STENT IN THE OSTIUM OF THE DIAGONAL BRANCH, WHICH THE GUIDE WIRE HAD PASSED THOUGH WHEN WIRING THE LAD. IT WAS STATED THAT THERE WAS A STRUT OF THIS PREVIOUSLY DEPLOYED STENT HANGING INTO THE LAD. IT WAS INDICATED THAT THIS WAS THE CAUSE OF THE EUPHORA BALLOON FAILING TO CROSS THE LESION. IT WAS ALSO REPORTED THAT THE TIP OF THE EUPHORA FULLY DETACHED AFTER THE DEVICE WAS REMOVED FROM THE PATIENT. THE DETACHED TIP WAS ON THE GUIDE WIRE OUTSIDE THE BODY SO THE TIP WAS PULLED OFF THE GUIDE WIRE AFTER REMOVIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13632302 ↗
• MalfunctionJul 2, 2021Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE EUPHORA BALLOON CATHETER TO TREAT A LESION. IT WAS REPORTED THAT ALL OF THE CONTRAST AND SALINE THAT WAS IN THE INDEFLATOR PUSHED THROUGH THE BALLOON. IT APPEARED THAT THE BALLOON HAD BURST. THE 3-WAY STOPCOCK WAS CHECKED TO MAKE SURE THAT WASN'T THE ISSUE, THE ISSUE APPEARED TO BE WITH THE BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105766 ↗
• MalfunctionJan 29, 2021Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE AN EUPHORA RX BALLOON TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT BALLOON BURST AT THE LUER/HUB OCCURRED DURING INFLATION AT 5-10 ATMS'S. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11251720 ↗
• MalfunctionSep 19, 2018Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  A EUPHORA BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 95% STENOSIS IN THE PROXIMAL-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. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. TWO BALLOONS WERE INSIDE THE GUIDE CATHETER, THE EUPHORA BALLOON AND AN UNKNOWN BRAND BALLOON. IT WAS REPORTED THAT THE DEVICES BECAME ENTANGLED AND COULD NOT BE ADVANCED. WHEN AN ATTEMPT WAS MADE TO REMOVE THE BALLOON, A DETACHMENT OCCURRED. THE EUPHORA BALLOON SEPARATED FROM THE DELIVERY SYSTEM. ALL COMPONENTS STAYED IN THE GUIDE CATHETER AND WERE REMOVED TOGETHER WHEN THE GUIDE WAS REMOVED. NO COMPONENTS REMAIN IN THE PATIENT. IT IS ALSO REPORTED THAT THE CATHETER BECAME STRETCHED. NO OTHER DEVICES WERE TRIED AFTER THEY REMOVED THE GUIDE. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7889664 ↗
• MalfunctionFeb 22, 2018Burst Container or Vessel; Burst Container or Vessel

  A SPRINTER OTW BALLOON CATHETER WAS USED TO TREAT A HEAVILY CALCIFIED RCA LESION. THE LESION HAD BEEN PREVIOUSLY STENTED. A EUPHORA BALLOON CATHETER WAS ALSO USED. IT WAS REPORTED THAT HE BALLOONS WERE INFLATED TO NOMINAL AND RATED PRESSURES WHEN THE BALLOONS RUPTURED DUE TO SHARP CALCIUM AND/OR STENT STRUTS WHICH MOST LIKELY IMPALED THE BALLOONS AT THE RIGHT RATED ATMS. MULTIPLE BALLOONS WERE USED AND BROKE DURING USE. EVERYTHING WAS REMOVED FROM THE BODY. THERE WERE NO BAD PATIENT OUTCOMES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7288218 ↗
• MalfunctionJul 4, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A EUPHORA RX BALLOON TO PRE-DILATE A SEVERELY CALCIFIED, MODERATELY TORTUOUS LAD LESION. IT WAS REPORTED THAT NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING AND NO ISSUES REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, NO RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT AT NOMINAL PRESSURE, THE BALLOON RUPTURED ON THE 2ND INFLATION. THERE WAS A GRADUAL DROP IN PRESSURE. THE BALLOON WAS RE-POSITIONED PRIOR TO THE BURST. NO PATIENT INJURY REPORTED. THE PROCEDURE WAS COMPLETED WITH AN NC EUPHORA OF THE SAME SIZE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6685344 ↗

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.