Euphora™ EUP2512XRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00643169560017), received between Apr 18, 2017 and Feb 18, 2026 — classified as 4 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (13 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA RX CORONARY BALLOON CATHETER, A BALLOON RUPTURE OCCURRED. IT IS BELIEVED A PIECE OF CALCIUM CAUSED THE RUPTURE. THIS CAUSED A DISSECTION OF THE VESSEL REQUIRING 5 STENTS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 24377375 ↗
• MalfunctionOct 20, 2025Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED THAT ONE NC EUPHORA RX BALLOON CATHETER EXPERIENCED A BALLOON BURST/RUPTURE/BALLOON LEAK OR CATHETER LEAK DURING A PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 23344397 ↗
• MalfunctionJun 13, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORIA CORONARY BALLOON CATHETER, THE BALLOON BURST DURING BALLOON INFLATION. THE ISSUE OCCURRED DURING THE FIRST INFLATION. AN INFLATION PRESSURE OF 12 ATM WAS APPLIED PRIOR TO THE BURST. THE LESION BEING TREATED WAS A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 70% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE BALLOON 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 STATED THAT THE PHYSICIAN HAD NO ISSUES WITH THE EUPHORIA RUPTURING AND IT WAS BELIEVED THAT THE BURST WAS DUE TO THE HEAVILY CALCIFIED ANATOMY BECAUSE AFTER THE EUPHORIA BURST, A SHOCKWAVE DEVICE WAS USED WHICH ALSO RUPTURED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201636 ↗
• MalfunctionMay 9, 2025Deflation Problem; Inflation Problem; Improper or Incorrect Procedure or Method; Difficult to Open or Remove Packaging Material; Material Deformation; Deflation Problem; Inflation Problem; Improper or Incorrect Procedure or Method; Difficult to Open or Remove Packaging Material; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ONE EUPHORA BALLOON CATHETER HAD INFLATION DIFFICULTIES DURING BALLOON INFLATION. THE DEVICE ALSO HAD BALLOON DEFLATION DIFFICULTIES FOLLOWING THE FIRST INFLATION, AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. PRIOR TO USE THE STYLETTE STUCK TO THE BALLOON WHEN IT WAS BEING REMOVED, AND A LITTLE MORE FORCE THAN USUAL WAS APPLIED TO REMOVE THE STYLETTE. THE STYLETTE STUCK TO THE USER'S GLOVE UPON REMOVAL. THE PATIENT HAD PRESENTED WITH A NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) AND THE LESION BEING TREATED WAS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE EUPHORA BALLOON CROSSED THE LESION, WAS INFLATED BUT THEN WAS UNABLE TO DEFLATE. THE BALLOON WAS ABLE TO BE PULLED OUT OVER THE NON-MEDTRONIC GUIDEWIRE AND REMOVED STILL INFLATED. IT WAS OBSERVED UPON REMOVAL THAT THE BALLOON TIP APPEARED TO BE FOLDED OVER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992394 ↗
• MalfunctionFeb 10, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, ONE EUPHORA RX CORONARY BALLOON CATHETER WAS UNABLE TO DEFLATE AT THE LESION SITE. THE GUIDE WIRE AND BALLOON WERE REMOVED WHILE THE BALLOON WAS STILL INFLATED. THE LESION BEING TREATED WAS A NON-CALCIFIED LESION WITH 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREPARATION WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT NOTED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT 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 21343169 ↗
• MalfunctionMay 11, 2023Deflation Problem; Deflation Problem

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A NON-TORTUOUS, MILDLY CALCIFIED LESION WITH 95% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED AT THE LESION SITE. MANY ATTEMPTS WERE MADE TO PULL NEGATIVE PRESSURE WITH NO SUCCESS. THE BALLOON WAS INFLATED IN AN ATTEMPT TO RUPTURE IT HOWEVER, THIS FAILED. THE INFLATED BALLOON WAS SUCCESSFULLY PULLED OUT OF THE VESSEL INTO THE GUIDE CATHETER AND REMOVED. IT WAS DETAILED THAT THE BALLOON WAS INFLATED TO 12 ATM AND A 50/50 SALINE/CONTRAST MIX WAS USED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910572 ↗
• MalfunctionMar 3, 2023Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENTS AND TWO EUPHORA RX PTCA BALLOON CATHETERS TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID SAPHENOUS VEIN GRAFT (SVG). THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED ON ANY OF THE DEVICES. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE 2.75 X 22MM RESOLUTE ONYX STENT BUT EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE TWO EUPHORA RX DEVICES AND THE 2.5 X 15 MM RESOLUTE ONYX STENT AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF THESE DEVICES. IT WAS REPORTED THAT THE FIRST STENT, THE 2.75 X 22MM RESOLUTE ONYX STENT FAILED TO CROSS THE LESION. IT WAS BELIEVED THAT THE STENT FAILED TO CROSS DUE TO HEAVY CALCIUM AND A POSSIBLE SURGICAL SUTURE AT THE SITE OF IMPLANT. THE STENT WAS REMOVED UNDEPLOYED. AN ATTEMPT WAS MADE TO PREDILATE THE SVG LESION WITH TWO 2.5 X 12 MM EUPHORA RX BALLOONS HOWEVER DURING BALLOON INFLATION THE BALLOONS BURST. IT WAS DETAILED THAT THE FIRST EUPHORA RX BALLOON BALLOON BURST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16477696 ↗
• MalfunctionMar 3, 2023Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENTS AND TWO EUPHORA RX PTCA BALLOON CATHETERS TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID SAPHENOUS VEIN GRAFT (SVG). THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED ON ANY OF THE DEVICES. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE 2.75 X 22MM RESOLUTE ONYX STENT BUT EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE TWO EUPHORA RX DEVICES AND THE 2.5 X 15 MM RESOLUTE ONYX STENT AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF THESE DEVICES. IT WAS REPORTED THAT THE FIRST STENT, THE 2.75 X 22MM RESOLUTE ONYX STENT FAILED TO CROSS THE LESION. IT WAS BELIEVED THAT THE STENT FAILED TO CROSS DUE TO HEAVY CALCIUM AND A POSSIBLE SURGICAL SUTURE AT THE SITE OF IMPLANT. THE STENT WAS REMOVED UNDEPLOYED. AN ATTEMPT WAS MADE TO PREDILATE THE SVG LESION WITH TWO 2.5 X 12 MM EUPHORA RX BALLOONS HOWEVER DURING BALLOON INFLATION THE BALLOONS BURST. IT WAS DETAILED THAT THE FIRST EUPHORA RX BALLOON BALLOON BURST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16477681 ↗
• MalfunctionSep 15, 2022Deflation Problem; Deflation Problem

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, NON-CALCIFIED LESION WITH 80-90% STENOSIS 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 NOT 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 WAS FAULTY AND THAT DEFLATION DIFFICULTIES OCCURRED. THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. THE BALLOON WAS REMOVED WHILE INFLATED WITH THE GUIDE AND THE WIRE. A NEW GUIDE AND WIRE WERE THEN USED TO SUCCESSFULLY DEPLOY A NEW BALLOON WITHOUT ANY ISSUES. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15426008 ↗
• MalfunctionJan 19, 2022Deflation Problem; Deflation Problem

  ONE EUPHORA RX BALLOON CATHETER WAS ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE 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 AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED. THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE BUT WAS ABLE TO DEFLATE ENOUGH TO GET BACK INTO THE GUIDE CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289148 ↗
• MalfunctionSep 28, 2021Deflation Problem; Deflation Problem

  A PATIENT WAS HAVING AN URGENT HEART CATHETERIZATION PERFORMED USING A EUPHORA DEVICE. IT WAS REPORTED THAT DURING INFLATION, ONLY ABOUT HALF OF THE BALLOON EXPANDED, AND AFTER ABOUT 5 SEC THE REMAINDER OF THE BALLOON INFLATED. WHEN THE INDEFLATOR WAS PULLED BACK THE BALLOON WOULD NOT DEFLATE, DESPITE MULTIPLE ATTEMPTS. AN ATTEMPT WAS MADE TO PULL THE BALLOON BACK INTO THE GUIDE CATHETER AND ON THE SECOND ATTEMPT IT WAS POSSIBLE TO GET THE DEVICE OUT WITH THE BALLOON STILL INFLATED. IT WAS STATED THAT THE INDEFLATOR HAD BEEN FILLED WITH THE APPROPRIATE SALINE/CONTRAST MIXTURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12539671 ↗
• MalfunctionAug 3, 2021Fracture; Fracture

  IT WAS INTENDED TO USE AN EUPHORA RX BALLOON TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION, WITH 95% STENOSIS IN THE DISTAL CIRCUMFLEX (CX) ARTERY. IT WAS REPORTED THAT THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES WERE IDENTIFIED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE LESION WAS NOT PRE-DILATED AND THE EUPHORA RX BALLOON DID NOT PASS A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT DURING DELIVERY, THE SHAFT OF THE BALLOON DELIVERY SYSTEM WAS FRACTURED AND THAT THE FRACTURE OCCURRED IN THE GUIDE CATHETER. IT WAS ALSO REPORTED THAT THE TIP OF THE DEVICE NEVER ENTERED THE PATIENT'S VESSEL. THE EUPHORA RX BALLOON SYSTEM WAS PULLED ON THE PROXIMAL END OF THE SHAFT TO REMOVE THE REMAINDER OF THE DEVICE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12265991 ↗
• MalfunctionMar 3, 2021Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A LESION. 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THE BALLOON BURST DURING FIRST INFLATION AT 10-14ATM. THE EUPHORA BALLOON WAS BEING USED TO POST DILATE A STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404243 ↗
• InjuryFeb 15, 2021Burst 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 A EUPHORA RX BALLOON CATHETER TO TREAT A SEVERELY CALCIFIED AND SEVERELY TORTUOUS LESION EXHIBITING 95% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED. 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 NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RESTRAIGHTENED DURING USE. IT WAS REPORTED THAT THE BALLOON RUPTURED OCCURRED AND UPON INSPECTION OUTSIDE THE PATIENT BODY, IT WAS NOTICED THAT PORTION OF THE BALLOON WAS DETACHED. THE PHYSICIAN BELIEVED THAT IT WAS LEFT IN THE TARGET VESSEL. PATIENT WAS SENT TO CABG AND HAD A HEART OPEN BYPASS.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 11326998 ↗
• InjuryOct 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, A RESOLUTE ONYX DRUG-ELUTING STENT WAS IMPLANTED IN THE LAD AND AN EUPHORA PTA BALLOON WAS ALSO USED DURING PROCEDURE. SAME DAY PATIENT SUFFERED ELEVATED CARDIAC ENZYMES. PATIENT RECOVERED. CEC ADJUDICATED NON-Q WAVE MI OF THE TARGET VESSEL LAD MEDTRONIC EXTENDED HISTORICAL PERI-PCI AND SCAI DEFINITION PERI-PCI. INVESTIGATOR ASSESSED EVENT IS UNLIKELY RELATED TO THE DEVICE AND ANTI PLATELET MEDICATION. SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 10625321 ↗
• MalfunctionJul 22, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION EX HIBITING 95% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO DIFFICULTY REMOVING THE STYLETTE FROM THE BALLOON PRIOR TO INSERTION. 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 INFLATION DIFFICULTIES OCCURRED DURING BALLOON INFLATION AT 8ATM. IT WAS ALSO REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED FOLLOWING FIRST INFLATION AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE BALLOON WAS REMOVED VERY SLOWLY FROM THE PATIENT WHILE INFLATED AT 8 ATM WITH NO DIFFICULTIES ENCOUNTERED, HOWEVER REMOVAL DIFFICULTIES WERE ENCOUNTERED WHEN REMOVING THE BALLOON THROUGH THE 6 FRENCH GUIDE. IT WAS NOTED THAT THE LENGTH OF THE STYLETTE APPEARED SHORTER THAN NORMAL. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10306769 ↗
• MalfunctionJul 21, 2020Burst Container or Vessel; Burst Container or Vessel

  A EUPHORIA RX PTCA BALLOON CATHETER WAS USED DURING A PROCEDURE TO TREAT A LESION. IT WAS REPORTED THAT THE BALLOON FAILED TO CROSS THE LESION AND THE BALLOON BURST AT 14ATM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301040 ↗
• InjuryJan 21, 2020Deflation Problem; Deflation Problem

  A EUPHORA RX PTCA BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 95% STENOSIS IN THE OM ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT 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 THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. IT WAS STATED THAT ATTEMPTS WERE MADE USING SEVERAL INDEFLATORS BUT TO NO AVAIL. SALINE WAS THEN INJECTED IN THE BALLOON AND INFLATED. THE DEVICE THEN DEFLATED AFTER 10 MORE MINUTES. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Injury

  MAUDE report 9609621 ↗
• MalfunctionJul 1, 2019Leak/Splash; Leak/Splash

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A EUPHORA RX PTCA BALLOON CATHETER TO TREAT A NON CALCIFIED LESION. THERE WERE NO ISSUES NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. THE LESION WAS NOT PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON COULD NOT BE INFLATED AND CONTRAST WAS OBSERVED TO BE LEAKING FROM THE BALLOON IMMEDIATELY UPON INFLATION ATTEMPT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8748774 ↗
• MalfunctionNov 21, 2018Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, 99% THROMBOTIC LESION LOCATED IN THE MID RCA. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE BALLOON WAS USED FOR PRE-DILATION FOLLOWING A THROMBECTOMY. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT A BALLOON BURST OCCURRED ON THE FIRST INFLATION TO 12ATM. IT IS INDICATED THAT THERE WAS A GRADUAL DROP IN PRESSURE AFTER INFLATION WAS ACHIEVED. THE PRESSURE LOAD WAS UNABLE TO BE ADVANCED AND THE REQUESTED PRESSURE COULD NOT BE MAINTAINED. IT IS REPORTED THAT BLOOD RETURN THROUGH THE CATHETER SHAFT WAS OBSERVED. THE PROCEDURE WAS COMPLETED USING A STENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8093929 ↗
• MalfunctionOct 1, 2018Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  AN ATTEMPT WAS MADE TO USE A EUPHORA RX PTCA BALLOON CATHETER TO TREAT A LESION. THE LESION WAS PRE-DILATED. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED PRIOR TO USE WITH NO ISSUES NOTED. THERE WERE NO ISSUES NOTED WHEN REMOVING DEVICE FROM THE HOOP. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE NOTED ADVANCING THE DEVICE TO THE LESION AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT NORMAL BALLOON INFLATION WAS CARRIED OUT. DEFLATION ISSUES OCCURRED LEADING TO REMOVAL DIFFICULTIES. THE INFLATED BALLOON WAS PULLED BACK INTO THE GUIDE CATHETER AND REMOVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7922839 ↗
• MalfunctionJul 27, 2017Deflation Problem; Difficult to Open or Remove Packaging Material; Deflation Problem; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A EUPHORA BALLOON TO TREAT A NON-CALCIFIED AND NON-TORTUOUS MID LAD LESION EXHIBITING 80% STENOSIS. NO ISSUES REMOVING THE DEVICE FROM THE HOOP/TRAY. THE PHYSICIAN REMOVED THE DEVICE FROM THE HOOP THEN WIPED IT DOWN WITH SALINE TO ACTIVATE THE COATING. SIGNIFICANT FORCE WAS REQUIRED TO REMOVE THE STYLET. THE DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. NO DIFFICULTIES WERE NOTED DURING INFLATION OF THE DEVICE. THE DEVICE WAS NOT MOVED OR RE-POSITIONED PRIOR TO THE DEFLATION DIFFICULTIES. A 50/50 CONCENTRATION OF CONTRAST/SALINE WAS USED. DURING THE PROCEDURE THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING DELIVERY AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT THE BALLOON WOULD NOT INITIALLY DEFLATE AT THE LESION SITE AFTER THE FIRST INFLATION. THE DEVICE THEN DEFLATED JUST ENOUGH TO PULL IT BACK OUT OF THE ARTERY AND OUT OF THE GUIDE WHILE STILL REMAINING PARTIALLY INFLATED THROUGHOUT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6749216 ↗
• MalfunctionJul 26, 2017Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  THE PHYSICIAN WAS INTENDING TO USE ON EUPHORA RX BALLOON CATHETER TO TREAT A MID LAD LESION EXHIBITING 99% STENOSIS. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND HOOP AND INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO REMOVE THE STYLETTE. FORCE WAS USED IN ATTEMPTING TO REMOVE THE STYLETTE. DEVICE WAS FLUSHED IN THE HOOP. THE STYLETTE RIPPED THE PHYSICIAN¿S GLOVE AND THE PHYSICIAN HAD TO RE-GLOVE. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6745632 ↗
• 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. NO ISSUES WERE NOTED REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. AS THE OPERATOR WAS ATTEMPTING TO PULL OUT THE STYLET, REMOVAL DIFFICULTIES WERE ENCOUNTERED, IT WAS REPORTED THAT THE STYLET HAD A BARB THAT CAUGHT THE GLOVE AND THEN JAMMED IN THE LUMEN. THE INCIDENT WAS NOTICED AT THE TIME OF PACKAGE OPENING AND REMOVAL FROM HOOP. THE HOOP WAS FLUSHED AND THE INCIDENT NOTICED PRIOR TO THE HOOP / BALLOON BEING PLACED IN A BOWL OF SALINE. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6744183 ↗
• MalfunctionJul 25, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A EUPHORA RX BALLOON TO TREAT A MODERATELY CALCIFIED AND TORTUOUS MID LAD EXHIBITING 80% STENOSIS. NO DAMAGE TO DEVICE PACKAGING AND NO ISSUES REMOVING THE DEVICE FROM THE HOOP / TRAY. THERE WERE NO DIFFICULTIES ENCOUNTERED WHEN REMOVING THE PROTECTIVE SHEATH OR STYLETTE. THE DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. A 50/50 CONCENTRATION OF CONTRAST/SALINE WAS USED BY THE PHYSICIAN. DURING THE PROCEDURE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING DELIVERY AND NO EXCESSIVE FORCE USED. NO ISSUES WERE NOTED DURING INFLATION OF THE DEVICE. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED AFTER THE FIRST INFLATION OF THE DEVICE, AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE DEVICE WAS NOT MOVED OR REPOSITIONED PRIOR TO THE TO THE DEFLATION DIFFICULTIES. THE PHYSICIAN REMOVED EVERYTHING TOGETHER BECAUSE THE DEVICE COULD NOT DEFLATE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6739769 ↗

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.