NC EuphoraRecalls & reported problems across all models
Medtronic, Inc. · 40 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 149
- Deaths reported
- 12
- Injuries reported
- 57
- Recalls
- 0
We found 40 models of NC Euphora by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 149 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 25, 2026 — classified as 12 deaths, 57 injuries, 80 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (75 reports).
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
Most reported NC Euphora problems
Device problems
- Detachment of Device or Device Component75
- Burst Container or Vessel48
- Deflation Problem44
- Difficult to Remove31
- Material Deformation29
- Adverse Event Without Identified Device or Use Problem17
- Inflation Problem17
- Leak/Splash12
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- No Consequences Or Impact To Patient38
- Insufficient Information30
- Device Embedded In Tissue or Plaque11
- Cardiac Arrest9
- Myocardial Infarction9
- Obstruction/Occlusion9
- Patient Problem/Medical Problem8
NC Euphora models
40 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NC Euphora™ NCEUP3020XCatheters, transluminal coronary angioplasty, percutaneous11 reports
- NC Euphora™ NCEUP3015XCatheters, transluminal coronary angioplasty, percutaneous11 reports
- NC Euphora™ NCEUP4012XCatheters, transluminal coronary angioplasty, percutaneous1 death10 reports
- NC Euphora™ NCEUP3012XCatheters, transluminal coronary angioplasty, percutaneous1 death8 reports
- NC Euphora™ NCEUP2515XCatheters, transluminal coronary angioplasty, percutaneous8 reports
- NC Euphora™ NCEUP3520XCatheters, transluminal coronary angioplasty, percutaneous1 death8 reports
- NC Euphora™ NCEUP32515XCatheters, transluminal coronary angioplasty, percutaneous7 reports
- NC Euphora™ NCEUP3512XCatheters, transluminal coronary angioplasty, percutaneous2 deaths7 reports
- NC Euphora™ NCEUP2512XCatheters, transluminal coronary angioplasty, percutaneous6 reports
- NC Euphora™ NCEUP3515XCatheters, transluminal coronary angioplasty, percutaneous2 deaths6 reports
- NC Euphora™ NCEUP2520XCatheters, transluminal coronary angioplasty, percutaneous5 reports
- NC Euphora™ NCEUP4512XCatheters, transluminal coronary angioplasty, percutaneous5 reports
- NC Euphora™ NCEUP4020XCatheters, transluminal coronary angioplasty, percutaneous5 reports
- NC Euphora™ NCEUP4508XCatheters, transluminal coronary angioplasty, percutaneous1 death4 reports
- NC Euphora™ NCEUP37515XCatheters, transluminal coronary angioplasty, percutaneous4 reports
- NC Euphora™ NCEUP3527XCatheters, transluminal coronary angioplasty, percutaneous4 reports
- NC Euphora™ NCEUP3008XCatheters, transluminal coronary angioplasty, percutaneous3 reports
- NC Euphora™ NCEUP4015XCatheters, transluminal coronary angioplasty, percutaneous1 death3 reports
- NC Euphora™ NCEUP4008XCatheters, transluminal coronary angioplasty, percutaneous3 reports
- NC Euphora™ NCEUP3027XCatheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Euphora™ NCEUP27520XCatheters, transluminal coronary angioplasty, percutaneous1 death2 reports
- NC Euphora™ NCEUP2506XCatheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Euphora™ NCEUP22520XCatheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Euphora™ NCEUP5008XCatheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Euphora™ NCEUP5012XCatheters, transluminal coronary angioplasty, percutaneous1 death2 reports
- NC Euphora™ NCEUP27508XCatheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Euphora™ NCEUP4515XCatheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Euphora™ NCEUP37512XCatheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Euphora™ NCEUP3508XCatheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Euphora™ NCEUP32520XCatheters, transluminal coronary angioplasty, percutaneous1 report
- NC Euphora™ NCEUP32512XCatheters, transluminal coronary angioplasty, percutaneous1 report
- NC Euphora™ NCEUP27512XCatheters, transluminal coronary angioplasty, percutaneous1 report
- NC Euphora™ NCEUP2508XCatheters, transluminal coronary angioplasty, percutaneous1 report
- NC Euphora™ NCEUP4520XCatheters, transluminal coronary angioplasty, percutaneous1 report
- NC Euphora™ NCEUP5015XCatheters, transluminal coronary angioplasty, percutaneous1 report
- NC Euphora™ NCEUP27506XCatheters, transluminal coronary angioplasty, percutaneous1 death1 report
- NC Euphora™ NCEUP2527XCatheters, transluminal coronary angioplasty, percutaneous1 report
- NC Euphora™ NCEUP4006XCatheters, transluminal coronary angioplasty, percutaneous1 report
- NC Euphora™ NCEUP37520XCatheters, transluminal coronary angioplasty, percutaneous1 report
- NC Euphora™ NCEUP2020XCatheters, transluminal coronary angioplasty, percutaneous1 report
Recent NC Euphora adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Deflation Problem
It was reported that during a procedure involving one NC Euphora balloon catheter deflation difficulties were encountered. The device would not deflate at the lesion site. The lesion being treated was a severely calcified, moderately tortuous lesion with 99% stenosis in the mid Circumflex (CX) 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 during delivery. During pre-dilation of the severe mid CX lesion with severe calcification, the balloon would not deflate. After several attempts of deflation with a suction syringe, the balloon was removed through the guide and sheath. Rewiring was done and the PCI was completed. No further patient complications were reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896651 ↗InjurySep 23, 2026Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component
It was reported that during a procedure involving one NC Euphora coronary balloon, a balloon rupture occurred during balloon inflation. The lesion being treated was non tortuous, non calcified with 90% stenosis in the proximal Right Coronary Artery (RCA). The device was inspected before use 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. Resistance was not encountered when advancing the device. The NC Euphora balloon was inflated once at 14ATM for 10 seconds in the proximal RCA lesion for post dilation of the stent when it ruptured. The NC Euhpora was pulled back into the right radial artery for removal. However difficulties were encountered removing the device. The device would not fit through the 6F radial sheath. It was attempted to pull the wire and guide out with balloon/catheter inside. However, the distal end/balloon tip of the NC Euphora balloon then fractured off and became dislodged in the patients radial artery. As a result, the patient was sent to vascular surgery for removal and further vessel injury. The detached part of the device was successfully removed. The
Patient problems: Insufficient Information
MAUDE report 50867418 ↗InjuryMar 6, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA RX CORONARY BALLOON CATHETER, THE BALLOON DETACHED IN VIVO DURING REMOVAL. IT WAS UNABLE TO SUCCESSFULLY RETRIEVE THE DETACHED PORTION OF THE DEVICE. THE PHYSICIAN STENTED ACROSS THE DETACHED PORTION OF THE BALLOON. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24530353 ↗MalfunctionFeb 25, 2026Deflation Problem; Material Deformation
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA RX CORONARY BALLOON CATHETER, DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE BALLOON WAS INFLATED TO 8-10ATM IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND COULD NOT BE DEFLATED. THE BALLOON WAS DISCONNECTED FROM THE SYRINGE AND THE BALLOON WAS REMOVED FROM THE PATIENT THROUGH THE GUIDE CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24442616 ↗InjuryFeb 9, 2026Deflation Problem
IT WAS REPORTED THAT DURING A COMPLEX PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE WITH LITHOTRIPSY, ONE NC EUPHORA CORONARY BALLOON FAILED TO DEFLATE AS EXPECTED. THE PATIENT REQUIRED HOSPITALIZATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24291096 ↗DeathJan 14, 2026Deflation Problem; Entrapment of Device; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA RX CORONARY BALLOON, DEFLATION DIFFICULTIES WERE ENCOUNTERED. DURING THE ELECTIVE OUTPATIENT PROCEDURE, THE PATIENT WAS NOTED TO HAVE PROXIMAL MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH IFR MEASUREMENT OF 0.59, CONSISTENT WITH SIGNIFICANT AND OBSTRUCTIVE CORONARY ARTERY DISEASE. A DECISION WAS MADE TO PREP THE LESION FURTHER WITH INTRAVASCULAR LITHOTRIPSY (IVL). THE IVL WAS PERFORMED WITH 3.0MM BALLOON ACROSS THE PROX-MID LAD WITH GOOD BALLOON EXPANSION. ONE ONYX FRONTIER STENT WAS DEPLOYED WITH GOOD BALLOON EXPANSION. THE 3.5MM NC BALLOON WAS USED TO POST-DILATE THE ONYX FRONTIER STENT. THERE WERE NO ISSUES WHEN ADVANCING THE NC BALLOON DISTAL TO THE STENT. THE STENT WAS INFLATED A FEW MILLIMETERS PROXIMAL TO THE EDGE OF THE DISTAL PORTION OF THE STENT. THE NC BALLOON WAS INFLATED TO 12 ATM. DURING POST STENT DILATIONS, THE 3.5MM NC EUPHORA BALLOON FAILED TO DEFLATE. IT WAS REPORTED THAT THERE WERE NO VISIBLE KINKS ON THE SHAFT OF THE BALLOON DEVICE. DOUBLE NEGATIVE PRESSURE WAS ATTEMPTED ON THE BALLOON, BUT THE BALLOON WOULD NOT DEFLATE AND REMAINED INFLATED. A SECOND INDEFLATOR WAS USED TO ATTEMPT TO DEFLATE TH
Patient problems: Cardiac Arrest; Device Embedded In Tissue or Plaque; Heart Block; Obstruction/Occlusion; Tachycardia; Ventricular Fibrillation
MAUDE report 24066518 ↗MalfunctionDec 2, 2025Burst Container or Vessel; Inflation Problem; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Positioning Problem; Burst Container or Vessel; Inflation Problem; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Positioning Problem
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA RX BALLOON CATHETER, BALLOON INFLATION DIFFICULTIES WERE ENCOUNTERED AND THE BALLOON BURST DURING INFLATION. IT WAS ALSO REPORTED THAT IT WAS A STRUGGLE TO DELIVER THE BALLOON. A PRESSURE OF 12 ATM WAS APPLIED HOWEVER THE BALLOON FAILED TO REACH 12 ATM AS IT KEPT LOSING PRESSURE. THE BALLOON WAS NOT FULLY INFLATING. THE BALLOON RUPTURED AND THEY WERE VERY PRE-OCCUPIED WITH FLUSHING THE CATHETER. THE LESION BEING TREATED WAS NON TORTUOUS, HAD CHRONIC TOTAL OCCLUSION OF 100% AND WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND 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 23693031 ↗InjuryNov 26, 2025Deflation Problem; Detachment of Device or Device Component; Positioning Problem; Deflation Problem; Detachment of Device or Device Component; Positioning Problem
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING WITH ONE NC EUPHORA RX CORONARY BALLOON CATHETER, DEFLATION DIFFICULTIES OCCURRED. THE BALLOON FAILED TO DEFLATE IN THE MID RIGHT CORONARY ARTERY (RCA) WHICH EXHIBITED SEVERE CALCIFICATION, MILD TORTUOSITY AND 99% LESION STENOSIS. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. AS A RESULT OF THE DEFLATION DIFFICULTIES, THE PATIENT REQUIRED A CORONARY ARTERY BYPASS SURGERY OF THE RCA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654249 ↗InjuryOct 16, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA CORONARY BALLOON, BALLOON DEFLATION DIFFICULTIES OCCURRED. THE BALLOON FAILED TO DEFLATE IN MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE PATIENT HAD TO GO TO SURGERY FOR REMOVAL OF THE DEVICE. THE DEVICE WAS STUCK INFLATED. BYPASS WAS PERFORMED. THE TARGET LESION EXHIBITED MODERATE TORTUOSITY AND MODERATE CALCIFICATION WITH 80 TO 85% LONG CALCIFIED. 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. PATIENT IS DOING WELL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23308247 ↗InjurySep 12, 2025Entrapment of Device; Deformation Due to Compressive Stress; Device Damaged by Another Device; Entrapment of Device; Deformation Due to Compressive Stress; Device Damaged by Another Device
DURING THE INITIAL PROCEDURE THE PATIENT PRESENTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION MANIFESTED BY A SEVERE 90% STENOSIS INVOLVING THE DISTAL LEFT MAIN CORONARY ARTERY EXTENDING INTO THE PROXIMAL SEGMENTS OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND LEFT CIRCUMFLEX CORONARY ARTERIES. THREE STENTS WERE IMPLANTED: A 3.0 X 15MM ONYX FRONTIER STENT, A 4.0 X 18 MM ONYX FRONTIER STENT, AND A 4.5 X 18MM ONYX FRONTIER STENT IMPLANTED. A 0.014 NON-MEDTRONIC WIRE WAS ADVANCED AND PLACED WITHIN THE DISTAL SEGMENT OF THE LAD. A 0.014 NON-MEDTRONIC WIRE WAS PLACED WITHIN THE LEFT CIRCUMFLEX CORONARY ARTERY. A 0.014 NON-MEDTRONIC WIRE WAS PLACED WITHIN THE 1ST OBTUSE MARGINAL BRANCH. NEXT, A 2.5 X 12 MM BALLOON WAS USED FROM PRIMARY ANGIOPLASTY OF THE DISTAL LEFT MAIN CORONARY EXTENDING INTO THE PROXIMAL LAD. AN IVUS CATHETER WAS THEN ADVANCED AND IVUS ASSESSMENT OF THE LEFT MAIN CORONARY ARTERY AND LAD WAS OBTAINED. NEXT, A 2.5 X 12 MM BALLOON WAS USED FROM FURTHER ANGIOPLASTY OF THE DISTAL LEFT MAIN CORONARY INTO THE PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY. AN ONYX FRONTIER 3 X 15 MM DRUG-ELUTING STENT WAS THEN ADVANCED AND PLACED WITHIN THE PROXIMAL LEFT CIRCUMFLEX CORONARY EXT
Patient problems: Ischemia
MAUDE report 23036039 ↗InjuryJul 14, 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 NC EUPHORA CORONARY BALLOON CATHETER DEFLATION DIFFICULTIES AND A DETACHMENT OCCURRED. THE BALLOON WAS UNABLE TO BE DEFLATED AFTER POST-DILATING A STENT. DIFFICULTIES WERE EXPERIENCED REMOVING THE DEVICE. THE BALLOON DETACHED FROM THE CATHETER DURING REMOVAL. THE LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PATIENT WAS SENT FOR BYPASS SURGERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; Obstruction/Occlusion
MAUDE report 22493272 ↗MalfunctionJul 3, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA RX BALLOON, THE BALLOON WOULD NOT INFLATE COMPLETELY AND WOULD NOT HOLD PRESSURE. IT WAS STATED THAT A BALLOON LEAK OCCURRED WHEN THE DEVICE WAS INSIDE THE PATIENT. THE ISSUE OCCURRED DURING THE FIRST BALLOON INFLATION. THERE WAS PARTIAL INFLATION OF THE BALLOON TO NOMINAL PRESSURE. THE DEVICE WAS BEING USED TO PRE-DILATE THE LESION. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE, NOR WAS EXCESSIVE FORCE USED DURING DELIVERY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE DEVICE WAS NOT MOVED OR REPOSITIONED WHILE INFLATED. THERE WAS NO BLOOD OBSERVED IN THE BALLOON. THE SAME INFLATION DEVICE WAS USED SUCCESSFULLY USED WITH OTHER DEVICES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393430 ↗MalfunctionJun 30, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA CORONARY BALLOON INFLATION DIFFICULTIES OCCURRED DURING BALLOON INFLATION. THE BALLOON INFLATED, BUT IT DID NOT HOLD PRESSURE AT 12 ATM. A DEVICE LEAK OCCURRED. THE ISSUE OCCURRED ON THE FIRST INFLATION. THE DEVICE WAS BEING USED TO POST-DILATE A DEPLOYED STENT. THE LESION BEING TREATED WAS NON-TORTUOUS, NON-CALCIFIED WITH 80% ST ENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. NEGATIVE PREP/PURGING PERFORMED ON THE DEVICE PRIOR TO USE 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 DEVICE WAS NOT MOVED OR REPOSITIONED WHILE INFLATED. THE SAME INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22356295 ↗MalfunctionJun 20, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA BALLOON CATHETER DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE BALLOON WAS VERY SLOW TO DEFLATE AT THE LESION SITE. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. 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 22296859 ↗InjuryJun 10, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER DRUG ELUTING CORONARY STENT AND ONE NC EUPHORA CORONARY BALLOON CATHETER, BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED FOR BOTH DEVICES. THE LESION BEING TREATED WAS NON-TORTUOUS, NON-CALCIFIED WITH 70% STENOSIS IN THE MID LEFT MAIN (LM) CORONARY ARTERY. THE DEVICES WERE BOTH INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED FOR BOTH DEVICES WITH NO ISSUES NOTED. THE ONYX FRONTIER DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE NC EUPHORA DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING BOTH DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF BOTH DEVICES. THE ONYX FRONTIER DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE INFLATION DEVICE WAS CHANGED BUT DEFLATION WAS STILL UNSUCCESSFUL. AN EMPTY 30CC SYRINGE WAS USED, WHICH ALLOWED THE BALLOON TO PARTIALLY DEFLATE AND BE REMOVED FROM THE DRUG ELUTING STENT. THIS WAS FOLLOWED BY CONTINUED SLOW DEFLATION AND REMOVAL. THE NC EUPHORA BALLOON WOULD NOT DEFLATE AT THE LESION SITE. THERE WERE MULTIPLE ATTEMPTS TO DEFLATE WITH THE INFLATION DEVICE WHICH WERE UNSUCCESSFUL. FOLLOWI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22174073 ↗
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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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