Euphora™ EUP2515XRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169560024), received between Jan 16, 2017 and Oct 29, 2025 — classified as 3 deaths, 3 injuries, 17 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Burst Container or Vessel; Inflation Problem; Leak/Splash; Burst Container or Vessel; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA CORONARY BALLOON CATHETER, BALLOON BURST, LEAK OR CATHETER LEAK OCCURRED. WHEN IT WAS ATTEMPTED TO INFLATION THE BALLOON IT WAS NOT VISIBLE ON X-RAY. ADDITIONAL CONTRAST WAS ADDED TO THE INDEFLATOR HOWEVER THE BALLOON WAS STILL NOT VISIBLE. IT WAS THEN DETERMINED FROM VIEWING THE X-RAY THAT THE CONTRAST MIXTURE USED WAS ADEQUATE FOR STENTS/BALLOONS. ANOTHER ATTEMPT WAS MADE TO INFLATE THE BALLOON HOWEVER IT BURST WHEN 10 ATM PRESSURE WAS APPLIED. THE LESION BEING TREATED WAS LOCATED IN THE DISTAL LEFT MAIN (LM) CORONARY ARTERY WITH MILD TORTUOSITY. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411788 ↗
• MalfunctionFeb 21, 2025Entrapment of Device; Detachment of Device or Device Component; Difficult to Advance; Material Deformation; Entrapment of Device; Detachment of Device or Device Component; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA BALLOON CATHETER, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THE CATHETER STRETCHED DUE TO GETTING STUCK ON THE NON-MEDTRONIC WIRE. THE DEVICE WAS DESCRIBED AS VERY TACKY WHEN LOADING ONTO THE WIRE, DESPITE PROPER PREPARATION. ONCE THE EUPHORA WAS INSIDE THE BODY, AN ATTEMPT TO MOVE THE DEVICE FORWARD RESULTING IN RESISTANCE, AND UPON PULLING IT BACK, IT GOT STUCK ON THE WIRE, CAUSING THE CATHETER TO STRETCH. THE DEVICE WAS SUBSEQUENTLY REMOVED. IT WAS NOT DIFFICULT TO REMOVE THE PROTECTIVE SHEATH OR THE PACKAGING STYLETTE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES, AND NEGATIVE PREP WAS PERFORMED SUCCESSFULLY. THE GUIDEWIRE LUMEN IN THE BALLOON DEVICE WAS FLUSHED BEFORE USE. THE LESION WAS NOT PRE-DILATED. THERE WAS NO EXCESSIVE FORCE USED DURING DELIVERY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE GUIDEWIRE WAS EXAMINED AND FLUSHED BEFORE USE WITH NO ISSUES OR KINKS NOTED. THE GUIDEWIRE WAS BEING BACK LOADED THROUGH THE TIP. OTHER BALLOONS HAD BEEN USED PREVIOUSLY ON THE WIRE WITHOUT ISSUES. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434073 ↗
• MalfunctionAug 26, 2024Deformation Due to Compressive Stress; Detachment of Device or Device Component; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA CORONARY BALLOON CATHETER TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. 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. IT WAS REPORTED THAT THE CATHETER DETACHED INTO TWO PIECES DURING ADVANCEMENT THROUGH GUIDE CATHETER. THE EUPHORA WAS INSERTED ON THE WIRE AND ADVANCED WITH NO FORCE NEEDED. UNDER FLUORO THE EUPHORA WAS CONTINUED TO BE ADVANCED, HOWEVER THE EUPHORA DID NOT EXIT THE GUIDING CATHETER TIP. THE EUPHORA ADVANCEMENT WAS STOPPED, AND THE GUIDING CATHETER, EUPHORA, AND WIRE WERE REMOVED IN ONE PIECE. THE EUPHORA WAS NEVER OUTSIDE THE GUIDE. ONCE OUTSIDE THE BODY, THE BALLOON AND WIRE WERE REMOVED FROM THE GUIDE. THE EUPHORA WAS IN TWO PIECES, BROKEN AT THE HYPO-TUBE. THE DISTAL PORTION OF THE BALLOON WITH PART OF THE CATHETER REMAINED ON THE WIRE. THE DETACHED PORTION OF DEVICE DOES NOT REMAIN IN THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063070 ↗
• MalfunctionJul 12, 2024Burst Container or Vessel; Leak/Splash; Material Deformation; Burst Container or Vessel; Leak/Splash; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA CORONARY BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION IN THE PROXIMAL 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 USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON BURST, LEAK OR THE CATHETER LEAKED DURING THE FIRST BALLOON INFLATION. IT WAS DETAILED THAT THE BALLOON WAS POSITIONED INTO PLACE, AND WHILE INFLATING, IT WAS SEEN TO BE LEAKING CONTRAST. THE PATIENT BECAME UNSTABLE AT THE TIME OF THE BALLOONING, AND THE REASON IS UNKNOWN. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Bradycardia; Insufficient Information; Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735345 ↗
• MalfunctionMay 24, 2024Deflation Problem; Deflation Problem

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA CORONARY BALLOON CATHETER TO TREAT A MILDLY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED 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 BALLOON DEFLATION DIFFICULTIES OCCURRED, AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THERE WAS PROLONGED INFLATION. THE DELIVERY SYSTEM WAS DISCONNECTED AND THE CONTRAST/SALINE WAS MANUALLY ASPIRATED OUT OF THE BALLOON TO DEFLATE IT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390874 ↗
• InjuryApr 26, 2024Deflation Problem; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn; Deflation Problem; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX BALLOON CATHETER TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND CIRCUMFLEX (CX) ARTERY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. IT WAS ALSO REPORTED THAT THE BALLOON BROKE, AND THAT THE WIRE REMAINED BROKEN IN THE VESSEL. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19190197 ↗
• DeathMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ONE LAUNCHER GUIDE CATHETER, ONE EUPHORA BALLOON CATHETER, FIVE NC EUPHORA BALLOON CATHETERS, AND ONE TELESCOPE GUIDE EXTENSION CATHETER (GEC) WERE ALSO USED DURING THE PROCEDURE. NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE. ON THE SAME DAY POST PROCEDURE THE PATIENT SUFFERED FROM A SPONTANEOUS MYOCARDIAL INFARCTION (MI) AND CARDIAC ARREST / SUDDEN CARDIAC DEATH. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE, HAD EATEN DINNER AND EVERYTHING WAS NORMAL WHEN SUDDENLY THE PATIENT COLLAPSED ON THE GROUND. THE PATIENT DID NOT HAVE ANY SYMPTOMS OF CHEST PAIN, DIAPHORESIS, NAUSEA, OR VOMITING. ADVANCED LIFE SAVING MEASURES WERE UTILIZED. EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED AND A FAMILY MEMBER TRIED TO DO SOME MOUTH-TO-MOUTH UNTIL THE AMBULANCE ARRIVED. WHEN THE AMBULANCE ARRIVED, THEY DETECTED ELECTROMECHANICAL DISSOCIATION (EMD) AND STARTED CARDIOPULMONARY RESUSCITATION (CPR) FOR 30 MINUTES BEFORE THE PATIENT ARRIVED TO THE EMERGENCY ROOM (ER). ADDITIONAL CPR WAS PERFORMED, HOWEVER, THIS WAS UNSUCCESSFUL IN OBTAINING BLOOD PRESSURE. TH

  Patient problems: Cardiac Arrest; Myocardial Infarction

  MAUDE report 18947598 ↗
• MalfunctionAug 25, 2023Burst 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 MILDLY TORTUOUS, NON-CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). 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 A BALLOON BURST, LEAK OR CATHETER LEAK OCCURRED. IT WAS DETAILED THAT DURING THE FIRST BALLOON INFLATION AT 14 ATM A BUBBLE WAS NOTED AT THE BALLOON TIP. THE DEVICE WAS REMOVED. THE BUBBLE WAS STILL EVIDENT IN THE BALLOON. IT WAS STATED THAT THE BALLOON RUPTURED ON THE BACK TABLE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623603 ↗
• MalfunctionJun 30, 2023Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A LESION LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY. IT WAS REPORTED THAT A BALLOON BURST OCCURRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238371 ↗
• MalfunctionJun 1, 2023Deflation Problem; Entrapment of Device; Material Deformation; Deflation Problem; Entrapment of Device; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA CATHETER BALLOON TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION IN THE PROXIMAL OBTUSE MARGINAL (OM). 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 BALLOON DEFLATION DIFFICULTIES OCCURRED. THE DEVICE WOULD NOT DEFLATE AFTER BEING INFLATED AT 8ATM FOR 20 SECONDS. THE BALLOON WAS PULLED BACK INTO THE GUIDE AND THE ENTIRE SYSTEM WAS REMOVED. THE BALLOON STILL DID NOT DEFLATE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038032 ↗
• MalfunctionApr 22, 2022Deflation Problem; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Deflation Problem; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  AN ATTEMPT WAS MADE TO USE A EUPHORA RX BALLOON CATHETER IN A NON-TORTUOUS, MILDLY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCEND ING (LAD) ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED AT THE LESION SITE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14185057 ↗
• InjuryApr 14, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE A EUPHORA RX BALLOON CATHETER DURING A PROCEDURE TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE BALLOON DETACHED DURING DELIVERY THROUGH THE VESSEL. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT IN THE OBTUSE MARGINAL (OM). THE BALLOON WAS INFLATED AND DEFLATED SUCCESSFULLY, HOWEVER; THERE WAS CALCIUM IN THE STENT PORTION AND IT IS BELIEVED THAT THE BALLOON GOT STUCK IN THE STENT STRUTS OR CALCIUM. THE PHYSICIAN ATTEMPTED TO SNARE THE DEVICE BUT THE DEVICE WOULD NOT MOVE. THE DEVICE WAS ATTEMPTED TO BE PULLED OUT BUT THE DETACHMENT OCCURRED. AN ATTEMPT WAS MADE TO SNARE THE DETACHED PORTION BUT WAS UNSUCCESSFUL. AN ATTEMPT WAS MADE TO TORQUE THE DETACHED PORTION BUT THIS WAS UNSUCCESSFUL, SO A NON-MEDTRONIC STENT WAS IMPLANTED TO COVER THE DETACHED PORTION. THE DETACHED PORTION REMAINS IN THE PATIENT. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14110166 ↗
• DeathOct 12, 2020Burst Container or Vessel; Device Dislodged or Dislocated; Burst Container or Vessel; Device Dislodged or Dislocated

  A EUPHORA RX PTCA BALLOON WAS USED DURING A PROCEDURE TO TREAT A MODERATE TORTUOSITY, SEVERELY CALCIFIED LESION EXHIBITING 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUES 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. THE DETACHED PORTION OF THE DEVICE REMAINS IN THE PATIENT. THE LESION WAS PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED DURING THE DELIVERY. IT WAS REPORTED THAT THE BALLOON BURST DURING THE SECOND INFLATION AT 26ATM. THE BALLOON DISLODGED IN RCA. PHYSICIAN WAS UNABLE TO RETRIEVE THE DISLODGED MATERIAL. FINAL RESULT WAS A TOTALLY OCCLUDED ARTERY WITH A FRESHLY DEPLOYED STENT AND PART OF THE DISTAL CORONARY WIRE TIP ALSO DISLODGED IN THE ARTERY. THE PATIENT DIED.

  Patient problems: Death; Device Embedded In Tissue or Plaque; Insufficient Information; Obstruction/Occlusion

  MAUDE report 10661158 ↗
• MalfunctionSep 9, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  A EUPHORA RX PTCA BALLOON CATHETER WAS USED DURING A PROCEDURE TO TREAT A LESION. THERE WAS 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. THE DEVICE DID NOT PASS THOUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. DURING THE VESSEL PREP THE BALLOON WENT TO THE LEGION SITE, THE INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. IT APPEARED THAT THERE WAS NO CONTRAST IN THE BALLOON AND THEY WERE UNABLE TO SEE IF THE BALLOON UP OR DOWN. THE BALLOON WAS THEN PREPPED AGAIN. THEN THEY USED THE INFLATION DEVICE TO INFLATE THE BALLOON TO 14 ATM. IT WAS REPORTED THAT WHEN THEY WANTED TO BRING THE BALLOON DOWN THE BALLOON WOULD NOT DEFLATE. THEY TRIED TO RAISE THE INFLATION AND LOWER THE INFLATION AND HAD NO SUCCESS AND BRING IT A BALLOON DOWN. FORTUNATELY THE VESSEL WAS LARGE ENOUGH THAT THEY WERE ABLE TO WITHDRAW THE BALLOON THE WIRE AND THE GUIDE. WITH NO SIGNIFICANT DAMAGE TO THE VESSEL. THEY WENT AHEAD AND STENTED THE VESSEL AND SAID THAT THERE IS NO PATIENT RELATED PROBLEMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507504 ↗
• MalfunctionAug 21, 2019Deflation Problem; Material Deformation; Deflation Problem; Material Deformation

  DURING A PROCEDURE A EUPHORA RX PTCA BALLOON CATHETER WAS INTENDED TO BE USED TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT DIFFICULTIES WERE ENCOUNTERED REMOVING THE STYLETTE AND PROTECTIVE COVER WHICH RESULTED IN A TEAR IN THE SCRUB PERSONNEL'S GLOVE AND DAMAGE TO THE BALLOON. IT WAS REPORTED THAT THE BALLOON WAS NOT FUNCTIONAL AFTER REMOVAL OF STYLETTE AND PROTECTIVE COVER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915473 ↗
• DeathFeb 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PCI PROCEDURE ONE 3.5 X 22MM RESOLUTE ONYX OTW DRUG ELUTING STENT WAS USED TO DIRECT STENT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 98% STENOSIS LOCATED IN THE PROXIMAL LAD. THE LESION IN THE PROXIMAL LAD WAS A SEVERE LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE LESION WAS NOT PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE 3.5 X 22MM RESOLUTE ONYX WAS INFLATED ONCE TO 15 ATM. A DECISION WAS MADE NOT TO GO HIGHER THAN 15ATM BECAUSE THE STENT WAS BEING OVER-SIZED. PREPROCEDURE STENOSIS WAS 90% WITH TIMI 3 FLOW. POST PROCEDURE STENOSIS WAS 0% WITH TIMI 3 FLOW. IT WAS INDICATED THAT THE MID-SECTION OF THE STENT AT THE TAKEOFF OF THE DIAGONAL BRANCH WAS NOT FULLY EXPANDED. THAT AREA WAS POST-DILATED TO EXPAND THE STENT AND THE FLOW TO THE DIAGONAL BRANCH WAS COMPROMISED. THERE WAS A SECOND WIRE PLACED IN THE DIAGONAL BRANCH AND A 2.0 X 15MM SPRINTER OTW BALLOON WAS PLACED THROUGH THE STENT STRUTS AND INF

  Patient problems: Death; Vascular Dissection

  MAUDE report 8347511 ↗
• MalfunctionAug 13, 2018Leak/Splash; Leak/Splash

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A LESION. THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT DURING INFLATION THE BALLOON WOULD NOT HOLD PRESSURE AND WAS LEAKING CONTRAST. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7777092 ↗
• MalfunctionApr 10, 2018Deflation Problem; Inflation Problem; Difficult to Remove; Deflation Problem; Inflation Problem; Difficult to Remove

  DURING THE PROCEDURE, AN EUPHORA PTCA BALLOON CATHETER WAS USED TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY, EXHIBITING 100% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. 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 WERE ENCOUNTERED DURING BALLOON INFLATION. IT WAS DESCRIBED THAT THERE WAS NO INFLATION BUT THEN A SUDDEN ABRUPT INFLATION OCCURRED. BALLOON DEFLATION DIFFICULTIES WERE ALSO NOTED AT THE LESION SITE, WHERE BY IT WAS DESCRIBED AS A NOT SMOOTH BALLOON DEFLATION DIFFICULTIES AND THE BALLOON DID NOT DEFLATE AT THE LESION SITE. IT WAS ALSO INFORMED THAT THERE WAS ALSO A DIFFICULTY REMOVING DEVICE PRIOR TO STENT DEPLOYMENT. THERE WERE MULTIPLE ATTEMPTS TO DEFLATE THE BALLOON. RETRACTION W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7410568 ↗
• MalfunctionDec 8, 2017Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN USED EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION, LOCATED AT THE MID LEFT ANTERIOR DESCENDING ARTERY, EXHIBITING 90% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THE DEVICE WAS BEING USED TO PRE-DILATE THE LESION. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE VESSEL WAS WIRED AND THEN THE NON MDT GUIDE CATHETER WAS INSERTED AND THEN THE BALLOON WAS ADVANCED TO THE CALCIFIED VESSEL. IT WAS REPORTED THAT BALLOON WENT UP DURING THE SECOND INFLATION AND BURST AT 14 ATMS. THE DEVICE WAS MOVED/REPOSITIONED PRIOR TO THE BURST. THERE WAS A SUDDEN DROP IN PRESSURE. IT WAS DESCRIBED THAT THERE WAS A CLEAN BREAK OF THE BALLOON AND A GOOD PORTION OF THE BALLOON MATERIAL WAS BUNCHED UP AT THE TIP AT 14 ATMS. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED AND THE PHYSICIAN COMPLETED THE PROCEDURE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7099187 ↗
• 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 AND THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NO DIFFICULTY WAS EXPERIENCED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS FLUSHED IN THE HOOP AND PLACED IN A BOWL OF SALINE TO ACTIVATE THE HYDROPHILIC COATING. IT WAS REPORTED THAT THE STYLETTE COULD NOT BE REMOVED AND IT WAS REPORTED THAT IT FELT LIKE IT WAS GLUED IN PLACE. THE PHYSICIAN WAS ABLE TO FINALLY REMOVE THE PROTECTIVE SHEATH USING FORCE, BUT IT CAME A PART CREATING A SHARP EDGE THAT TORE HIS GLOVE. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6745784 ↗
• MalfunctionJul 4, 2017Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A EUPHORA BALLOON CATHETER TO TREAT A NON -CALCIFIED AND MILDLY TORTUOUS DISTAL CX LESION EXHIBITING 99% STENOSIS. IT WAS REPORTED THAT NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. NO ISSUES NOTED REMOVING THE DEVICE FROM THE HOOP/TRAY OR WHEN REMOVING THE PROTECTIVE SHEATH / PACKAGING STYLET FROM THE DEVICE. THE DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. 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 USED. THE 50/50 CONCENTRATION OF CONTRAST / SALINE WAS USED BY THE PHYSICIAN. INFLATION DIFFICULTIES (SLOW INFLATION) WERE NOTED AT 8ATM WITH SLOW CONTRAST. IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE AND WAS REMOVED WHILE STILL INFLATED. DEVICE WAS NOT MOVED OR RE-POSITIONED PRIOR TO THE DEFLATION DIFFICULTIES. NO INTERVENTION WAS USED TO REMOVE THE DEVICE. WIRE AND GUIDE WERE REMOVED WITH THE BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6685280 ↗
• MalfunctionMar 23, 2017Leak/Splash; Leak/Splash

  THE PHYSICIAN INTENDED TO USE A SC EUPHORA BALLOON CATHETER TO PRE-DILATE A SEVERELY CALCIFIED TARGET LESION WITH SHARP PLAQUE. NO DAMAGE WAS NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES REPORTED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT DURING THE FIRST BALLOON INFLATION, THE BALLOON RUPTURED AND THAT THERE WAS A SUDDEN DROP IN PRESSURE NOTED ON THE INFLATION DEVICE. FOLLOWING THIS, BALLOON REMOVAL DIFFICULTIES WERE ENCOUNTERED. WHEN THE BALLOON WAS REMOVED AS NORMAL OVER THE WIRE, IT WAS BUNCHED UP TOWARD THE TIP OF THE DEVICE. IT IS REPORTED THAT THE SAME INFLATION DEVICE WAS USED FOR ALL INFLATIONS PRE AND POST. THERE IS NO PLANNED EXTRA PROCEDURE AT THIS TIME. AT THE END OF THE CASE THE PATIENT WAS FINE AND WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6427304 ↗
• InjuryJan 16, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A EUPHORA RX BALLOON TO TREAT A MODERATELY CALCIFIED AND SLIGHTLY TORTUOUS PROXIMAL LAD LESION. NO DAMAGE NOTED TO DEVICE PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE TO THE LESION. IT WAS REPORTED THAT THE DEVICE WAS INFLATED IN THE RCA ONCE WITH NO ISSUES. IT WAS THEN DELIVERED TO THE LAD AND INFLATED ONCE. THE BALLOON STARTED LOSING PRESSURE AT 13 ATMS. THE DEVICE WAS NOT MOVED OR RE-POSITIONED PRIOR TO THE BURST. AFTER THE CASE, WHEN THE PHYSICIAN REMOVED AND ATTEMPTED TO RE-INFLATE THE BALLOON OUTSIDE THE BODY. HE NOTICED A PIN POINT HOLE THAT SALINE SHOT OUT OF WITH SUBSTANTIAL PRESSURE. IT WAS NOT A LONGITUDINAL SPLIT. THE BALLOON CAUSED A DISSECTION. THE PHYSICIAN PUT IN TWO STENTS TO COVER. PATIENT IS DOING WELL.

  Patient problems: Intimal Dissection

  MAUDE report 6253486 ↗

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.