EuphoraRecalls & reported problems across all models
Medtronic, Inc. · 62 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Euphora model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 183
- Deaths reported
- 6
- Injuries reported
- 40
- Recalls
- 2
We found 62 models of Euphora by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 183 adverse event reports in the FDA's MAUDE database, received between Jan 16, 2017 and May 26, 2026 — classified as 6 deaths, 40 injuries, 137 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (65 reports).
2 FDA recall records name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Euphora recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 62 of these models · Recall details · FDA record ↗
- Jul 13, 2017Terminated
Stylette removal difficulties on the Euphora and Solarice products.
Z-3136-2017 · Root cause: Process design · names 62 of these models · Recall details · FDA record ↗
Most reported Euphora problems
Device problems
- Burst Container or Vessel65
- Deflation Problem59
- Detachment of Device or Device Component49
- Material Deformation33
- Leak/Splash24
- Difficult to Remove22
- Difficult to Open or Remove Packaging Material15
- Inflation Problem12
Patient problems
- No Clinical Signs, Symptoms or Conditions77
- No Consequences Or Impact To Patient60
- Insufficient Information21
- Device Embedded In Tissue or Plaque10
- Vascular Dissection10
- Myocardial Infarction6
- Injury5
- No Known Impact Or Consequence To Patient5
Euphora models
62 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Euphora™ EUP2512XCatheters, transluminal coronary angioplasty, percutaneous2 recalls28 reports
- Euphora™ EUP2515XCatheters, transluminal coronary angioplasty, percutaneous2 recalls3 deaths23 reports
- Euphora™ EUP2012XCatheters, transluminal coronary angioplasty, percutaneous2 recalls15 reports
- Euphora™ EUP3015XCatheters, transluminal coronary angioplasty, percutaneous2 recalls1 death15 reports
- Euphora™ EUP2520XCatheters, transluminal coronary angioplasty, percutaneous2 recalls14 reports
- Euphora™ EUP3020XCatheters, transluminal coronary angioplasty, percutaneous2 recalls12 reports
- Euphora™ EUP1512XCatheters, transluminal coronary angioplasty, percutaneous2 recalls11 reports
- Euphora™ EUP3012XCatheters, transluminal coronary angioplasty, percutaneous2 recalls10 reports
- Euphora™ EUP2015XCatheters, transluminal coronary angioplasty, percutaneous2 recalls9 reports
- Euphora™ EUP2020XCatheters, transluminal coronary angioplasty, percutaneous2 recalls6 reports
- Euphora™ EUP2510XCatheters, transluminal coronary angioplasty, percutaneous2 recalls5 reports
- Euphora™ EUP1520XCatheters, transluminal coronary angioplasty, percutaneous2 recalls4 reports
- Euphora™ EUP1515XCatheters, transluminal coronary angioplasty, percutaneous2 recalls3 reports
- Euphora™ EUP3010XCatheters, transluminal coronary angioplasty, percutaneous2 recalls3 reports
- Euphora™ EUP3512XCatheters, transluminal coronary angioplasty, percutaneous2 recalls2 deaths3 reports
- Euphora™ EUP2010XCatheters, transluminal coronary angioplasty, percutaneous2 recalls2 reports
- Euphora™ EUP22512XCatheters, transluminal coronary angioplasty, percutaneous2 recalls2 reports
- Euphora™ EUP22520XCatheters, transluminal coronary angioplasty, percutaneous2 recalls2 reports
- Euphora™ EUP2506XCatheters, transluminal coronary angioplasty, percutaneous2 recalls2 reports
- Euphora™ EUP2530XCatheters, transluminal coronary angioplasty, percutaneous2 recalls2 reports
- Euphora™ EUP3515XCatheters, transluminal coronary angioplasty, percutaneous2 recalls2 reports
- Euphora™ EUP2030XCatheters, transluminal coronary angioplasty, percutaneous2 recalls1 report
- Euphora™ EUP22506XCatheters, transluminal coronary angioplasty, percutaneous2 recalls1 report
- Euphora™ EUP22510XCatheters, transluminal coronary angioplasty, percutaneous2 recalls1 report
- Euphora™ EUP27510XCatheters, transluminal coronary angioplasty, percutaneous2 recalls1 report
- Euphora™ EUP27515XCatheters, transluminal coronary angioplasty, percutaneous2 recalls1 report
- Euphora™ EUP27520XCatheters, transluminal coronary angioplasty, percutaneous2 recalls1 report
- Euphora™ EUP3030XCatheters, transluminal coronary angioplasty, percutaneous2 recalls1 report
- Euphora™ EUP32520XCatheters, transluminal coronary angioplasty, percutaneous2 recalls1 report
- Euphora™ EUP3520XCatheters, transluminal coronary angioplasty, percutaneous2 recalls1 report
- Euphora™ EUP3530XCatheters, transluminal coronary angioplasty, percutaneous2 recalls1 report
- Euphora™ EUP1506XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP1510XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP2006XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP2025XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP22515XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP22525XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP2525XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP27506XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP27512XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP3006XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP3025XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP32506XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP32510XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP32512XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP32515XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP32525XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP3506XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP3510XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP3525XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP37510XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP37512XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP37515XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP37520XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP37525XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP4006XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP4010XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP4012XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP4015XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP4020XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP4025XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
- Euphora™ EUP4030XCatheters, transluminal coronary angioplasty, percutaneous2 recalls0 reports
Recent Euphora adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2026Entrapment of Device; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA RX CORONARY BALLOON CATHETER, DIFFICULTIES WERE ENCOUNTERED WHEN REMOVING THE BALLOON OFF THE GUIDEWIRE FOLLOWING BALLOON INFLATION. THE INFLATION PRESSURE APPLIED TO THE BALLOON PRIOR TO DIFFICULTIES WAS NOMINAL. THERE WAS NO ISSUE DURING DELIVERY OF THE GUIDEWIRE TO/ACROSS THE LESION SITE. THE DIFFICULTY OCCURRED DURING POST INFLATION OF THE BALLOON. THE BALLOON WAS USED THREE TIMES AND AFTER USE, IT BECAME HUNG UP ON THE WIRE WHEN ATTEMPTING REMOVAL. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS 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 25276934 ↗MalfunctionMar 24, 2026Burst Container or Vessel; Improper or Incorrect Procedure or Method
DURING A PROCEDURE INVOLVING ONE EUPHORA RX BALLOON CATHETER A BALLOON BURST/RUPTURE OCCURRED DURING BALLOON INFLATION. IT WAS NOTED THAT THE BALLOON WAS NOT OVER INFLATED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24673276 ↗InjuryMar 24, 2026Burst Container or Vessel; Leak/Splash; Material Deformation
IT WAS REPORTED THAT DURING A PROCEDURE ONE EUPHORA RX CORONARY BALLOON AND ONE 2.0 X 15 MM ONYX DRUG ELUTING STENT WERE USED. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE CIRCUMFLEX (CX) AND OBTUSE MARGINAL (OM) WHICH EXHIBITED NO TORTUOSITY AND NO CALCIFICATION. 30-40% LESION STENOSIS WAS PRESENT IN THE OSTIAL CX AND 80% LESION STENOSIS WAS PRESENT IN THE OM. NO ISSUES WERE NOTED ON THE DEVICES PRIOR TO USE. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH THE EUPHORA BALLOON WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHILE ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE BALLOON BURST WHEN INFLATED TO NOMINAL PRESSURE. AFTER REMOVAL OF THE BALLOON, IMAGING WAS PERFORMED TO ASSESS THE VESSEL AND CONTRAST DYE STATUS, WHICH INITIALLY MADE THE VESSEL APPEAR TO BE DISSECTED. THE PHYSICIAN TOOK ANOTHER PICTURE AFTER BALLOON REMOVAL, AND THE CONTRAST DYE WAS GONE. THE BALLOON WAS EVALUATED OUTSIDE THE BODY AND DEMONSTRATED A RUPTURED BALLOON. THE ONYX DEVICE FAILED TO CROSS THE LESION. THE PATIENT WAS ASYMPTOMATIC AND THERE APPEARED TO BE NO EXTRAVASATION. BEDSIDE ECHO REVEALED NO PERICARDIAL EFFUSION. GIVEN THE PATIE
Patient problems: Vascular Dissection
MAUDE report 24673197 ↗MalfunctionMar 11, 2026Burst Container or Vessel; Improper or Incorrect Procedure or Method; Material Deformation
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA RX CORONARY BALLOON CATHETER, THE BALLOON BURST DURING BALLOON INFLATION. THE TARGET LESION EXHIBITED SEVERE TORTUOSITY, SEVERE CALCIFICATION AND 99% LESION STENOSIS. THE BALLOON RUPTURED DURING INFLATION WHILE ATTEMPTING TO PREPARE THE LESION FOR A LARGER BALLOON TO CROSS. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24570620 ↗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 ↗InjuryFeb 10, 2026Burst Container or Vessel; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA RX CORONARY BALLOON CATHETER, DURING INFLATION THE BALLOON RUPTURED WHILE POST DILATING A STENT AT 22 ATM. THIS EUPHORA BALLOON WAS USED FOR PRE-DILATION OF THE LESION AND WAS THEN REINSERTED TO POST-DILATE THE STENT. THE LESION BEING TREATED WAS MILDLY TORTUOUS, MILDLY CALCIFIED WITH 95% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. DURING REMOVAL OF THE DEVICE, A DETACHMENT OCCURRED AT THE BALLOON. THE DETACHED PORTION OF DEVICE REMAINS IN PATIENT. A 3.0 STENT WAS PLACED TO TRAP THE BALLOON MATERIAL BETWEEN THE STENT AND THE ARTERIAL WALL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24303932 ↗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 ↗MalfunctionNov 13, 2025Deformation Due to Compressive Stress; Detachment of Device or Device Component; Positioning Problem; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Positioning Problem
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA CORONARY BALLOON CATHETER, THE DEVICE DETACHED, CRACKED OR FRACTURED. THE DEVICE WAS PUSHED AND TWISTED IN ORDER TO ADVANCE IT AND NEVER CROSSED THE LESION. THE DEVICE COMPLETELY BROKE AS IT WAS BEING PULLED OUT OF THE PATIENT. THE BREAK OCCURRED AT THE CATHETER. THE DETACHED PORTION WAS EXPOSED AT THE SHEATH AND WAS ABLE TO BE REMOVED FROM THE BODY. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 99% STENOSIS. 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. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23541716 ↗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 ↗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 ↗DeathSep 15, 2025Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA CORONARY BALLOON CATHETER, BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE BALLOON WAS DELIVERED AND INFLATED WITHOUT ISSUE. THE BALLOON WAS UNABLE TO DEFLATE AT THE LESION SITE. THE BALLOON WAS INTENTIONALLY RUPTURED AND THEN IT WAS ATTEMPTED TO REMOVE IT. THE INFLATION PRESSURE APPLIED WAS 20 ATM. THE BALLOON SHAFT FRACTURED AND WAS REMOVED IN TWO PIECES. IT WAS NOTED THAT THERE WAS NO KINKING OF THE SHAFT WHEN THE BALLOON WAS BEING ADVANCED. THE ISSUE OCCURRED ON FIRST INFLATION. THE LESION BEING TREATED WAS SEVERELY TORTUOUS LOCATED IN THE OSTIUM/PROXIMAL LEFT MAIN (LM) CORONARY ARTERY/ LEFT ANTERIOR DESCENDING (LAD) ARTERY/ CIRCUMFLEX (CX) ARTERY. THE PATIENT SUFFERED CARDIAC ARREST REQUIRING PLACEMENT OF TWO NON-MEDTRONIC HEART PUMPS. THE PATIENT SUBSEQUENTLY DIED.
Patient problems: Cardiac Arrest
MAUDE report 23050680 ↗MalfunctionSep 3, 2025Deformation Due to Compressive Stress; Difficult to Open or Remove Packaging Material; Material Deformation; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Difficult to Open or Remove Packaging Material; Material Deformation; Material Split, Cut or Torn
IT WAS REPORTED THAT AFTER REMOVAL OF ONE EUPHORA RX CORONARY BALLOON CATHETER FROM THE HOOP, THE STYLET WAS FOUND TO BE MELTED INTO THE BALLOON AND CUT THROUGH THE PHYSICIAN'S GLOVE. THE CATHETER/DELIVERY SYSTEM WAS NOTED TO BE DEFORMED AT THE TIP. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22950717 ↗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 ↗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 ↗DeathMay 16, 2025Deflation Problem; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A EUPHORA BALLOON RX, THE DEVICE BECAME STUCK IN THE INFLATED POSITION WITHIN THE LEFT MAIN TO CIRCUMFLEX ARTERY. THE COMPLICATION AROSE DURING FINAL POST-DILATATION OF STENTS IN THE LEFT MAIN CORONARY ARTERY EXTENDING INTO THE LEFT CIRCUMFLEX ARTERY, WHEN A 3.5X15 MM NON-MEDTRONIC NC BALLOON FRACTURED. THE DISTAL (MONORAIL) OPAQUE TIP SEPARATED FROM THE HYPOTUBE AND REMAINED WITHIN THE CORONARY ARTERY, STUCK IN THE PREVIOUSLY IMPLANTED STENT IN THE LEFT MAIN TO THE CIRCUMFLEX ARTERY. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE FRACTURED NON-MEDTRONIC BALLOON. DURING EFFORTS TO RETRIEVE THE NON-MEDTRONIC DEVICE, A EUPHORA BALLOON RX WAS INTRODUCED AND SUBSEQUENTLY BECAME STUCK IN THE SAME SEGMENT, ALSO IN THE INFLATED POSITION. AN ATTEMPT WAS MADE TO DEFLATE THE EUPHORA BALLOON BY CUTTING THE SHAFT, BUT THIS WAS UNSUCCESSFUL. SEVERAL ADDITIONAL RETRIEVAL EFFORTS FAILED. THE PATIENT WAS ULTIMATELY REFERRED FOR SURGICAL INTERVENTION FOR POTENTIAL DEVICE RETRIEVAL AND CORONARY ARTERY BYPASS GRAFTING (CABG).
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information
MAUDE report 22037070 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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