EverCrossRecalls & reported problems across all models
Ev3, Inc · 114 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 213
- Deaths reported
- 4
- Injuries reported
- 67
- Recalls
- 0
We found 114 models of EverCross by Ev3, Inc in the FDA's device registry (GUDID). Together they are named in 213 adverse event reports in the FDA's MAUDE database, received between Nov 1, 2016 and Sep 30, 2026 — classified as 4 deaths, 67 injuries, 142 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (156 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 EverCross problems
Device problems
- Burst Container or Vessel156
- Detachment of Device or Device Component42
- Difficult to Remove30
- Deflation Problem16
- Leak/Splash16
- Inflation Problem10
- Difficult to Advance6
- Adverse Event Without Identified Device or Use Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions99
- No Consequences Or Impact To Patient72
- Patient Problem/Medical Problem18
- Device Embedded In Tissue or Plaque12
- Insufficient Information11
- Injury4
- Unspecified Tissue Injury4
- Obstruction/Occlusion3
EverCross models
114 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- EverCross™ AB35W06060135Catheter, angioplasty, peripheral, transluminal7 reports
- EverCross™ AB35W06200135Catheter, percutaneous1 death6 reports
- EverCross™ AB35W06200135Catheter, angioplasty, peripheral, transluminal5 reports
- EverCross™ AB35W07040080Catheter, angioplasty, peripheral, transluminal5 reports
- EverCross™ AB35W05150135Catheter, angioplasty, peripheral, transluminal4 reports
- EverCross™ AB35W05200135Catheter, angioplasty, peripheral, transluminal4 reports
- EverCross™ AB35W06150135Catheter, angioplasty, peripheral, transluminal4 reports
- EverCross™ AB35W07060135Catheter, angioplasty, peripheral, transluminal4 reports
- EverCross™ AB35W06040080Catheter, angioplasty, peripheral, transluminal4 reports
- EverCross™ AB35W06200135Catheter, angioplasty, peripheral, transluminal4 reports
- EverCross™ AB35W12060080Catheter, angioplasty, peripheral, transluminal4 reports
- EverCross™ AB35W06150135Catheter, percutaneous3 reports
- EverCross™ AB35W07100135Catheter, angioplasty, peripheral, transluminal3 reports
- EverCross™ AB35W04150135Catheter, angioplasty, peripheral, transluminal3 reports
- EverCross™ AB35W05040135Catheter, angioplasty, peripheral, transluminal3 reports
- EverCross™ AB35W05080135Catheter, angioplasty, peripheral, transluminal3 reports
- EverCross™ AB35W06040080Catheter, angioplasty, peripheral, transluminal3 reports
- EverCross™ AB35W07040135Catheter, angioplasty, peripheral, transluminal3 reports
- EverCross™ AB35W08040080Catheter, angioplasty, peripheral, transluminal3 reports
- EverCross™ AB35W10060080Catheter, angioplasty, peripheral, transluminal3 reports
- EverCross™ AB35W05040135Catheter, angioplasty, peripheral, transluminal3 reports
- EverCross™ AB35W05100135Catheter, angioplasty, peripheral, transluminal3 reports
- EverCross™ AB35W06120135Catheter, angioplasty, peripheral, transluminal3 reports
- EverCross™ AB35W09040080Catheter, angioplasty, peripheral, transluminal1 death3 reports
- EverCross™ AB35W10040080CATHETER, PERCUTANEOUS3 reports
- EverCross™ AB35W04080135Catheter, percutaneous2 reports
- EverCross™ AB35W05200135Catheter, percutaneous2 reports
- EverCross™ AB35W06040135Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W07040135Catheter, percutaneous2 reports
- EverCross™ AB35W07080080Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W07150135Catheter, percutaneous2 reports
- EverCross™ AB35W08060080Catheter, percutaneous2 reports
- EverCross™ AB35W05100135Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W06080135Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W06100135Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W06120135Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W08040135Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W08060135Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W08080080Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W10040080Catheter, percutaneous2 reports
- EverCross™ AB35W10060135Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W04200135Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W05040080Catheter, angioplasty, peripheral, transluminal1 death2 reports
- EverCross™ AB35W05150135Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W06030135Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W06040135Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W06060135Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W06080135Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W06150135Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W07040080Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W07080080Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W08020080Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W08040080Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W08040135Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W08060080Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W08080080Catheter, angioplasty, peripheral, transluminal2 reports
- EverCross™ AB35W03080135Catheter, percutaneous1 report
- EverCross™ AB35W04150135Catheter, percutaneous1 report
- EverCross™ AB35W05060135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W05200080Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W06040040Catheter, percutaneous1 report
- EverCross™ AB35W06060135Catheter, percutaneous1 report
- EverCross™ AB35W06080135Catheter, percutaneous1 report
- EverCross™ AB35W06120135Catheter, percutaneous1 report
- EverCross™ AB35W06200080Catheter, percutaneous1 report
- EverCross™ AB35W07040080Catheter, percutaneous1 report
- EverCross™ AB35W07060080Catheter, percutaneous1 report
- EverCross™ AB35W07060135Catheter, percutaneous1 report
- EverCross™ AB35W07120135Catheter, percutaneous1 report
- EverCross™ AB35W07200135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W08040080Catheter, percutaneous1 report
- EverCross™ AB35W08080080Catheter, percutaneous1 report
- EverCross™ AB35W08080135Catheter, percutaneous1 report
- EverCross™ AB35W10040135Catheter, percutaneous1 report
- EverCross™ AB35W04120135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W05020135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W05040080Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W05120135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W06020135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W06030135Catheter, angioplasty, peripheral, transluminal1 death1 report
- EverCross™ AB35W06040135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W06080080Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W07020135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W07060080Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W07100135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W08020080Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W09040080Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W09060080Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W09080080Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W04040135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W04060080Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W03020135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W04040135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W04080135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W04120135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W05060080Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W05060135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W05080135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W06020135Catheter, angioplasty, peripheral, transluminal1 report
- EverCross™ AB35W06100080Catheter, angioplasty, peripheral, transluminal1 report
Recent EverCross adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Burst Container or Vessel
It was reported that during a procedure using an Evercross PTA balloon catheter, for the treatment of a plaque lesion in the mid section of the right superficial femoral artery (vessel diameter; 6.5 mm), the balloon experienced a pinhole type balloon burst (Balloon Burst AT, BELOW, or UNKNOWN Rated Burst Pressure) on the first inflation. The vessel was post- dilated. The device did not pass through a previously deployed stent. No resistance was encountered when advancing the device. The balloon was inflated with a (Cook Medical) inflation device and 50/50 contrast inflation fluid was used. No damage was noted to the packaging and no issues were noted when removing the device from the hoop/tray. The instructions for use were followed without issue. It is not known at what pressure the balloon burst. The balloon did not detach during the procedure. The device was safely removed from the patient. The procedure was completed using a new (Medtronic) device. The patient was reported as alive, with no injury. No injury or intervention was associated with this event. No patient symptoms or complications have been reported as a result of this event. It was reported that there was a 3 minute
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947116 ↗MalfunctionApr 26, 2026Burst Container or Vessel
IT WAS REPORTED THAT DURING A PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035 AND NANOCROSS ELITE BALLOON CATHETERS TO TREAT A SEVERELY CALCIFIED TARGET LESION IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY, THE EVERCROSS 035 BALLOON BURST CIRCUMFERENTIALLY/RADIALLY ON THE FIRST INFLATION. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE WITH 50/50 CONTRAST, NO EMBOLIC PROTECTION WAS USED, THE VESSEL WAS PRE-DILATED, THE BALLOON DID NOT DETACH AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A NEW BALLOON CATHETER WAS THEN USED. IT WAS FURTHER REPORTED THAT DURING CONTINUED TREATMENT WITH THE NANOCROSS ELITE BALLOON CATHETER, THE BALLOON BURST CIRCUMFERENTIALLY/RADIALLY ON THE FIRST INFLATION. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE WITH 50/50 CONTRAST, NO EMBOLIC PROTECTION WAS USED, THE VESSEL WAS POST-DILATED, THE BALLOON DID NOT DETACH AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS ABORTED FOLLOWING THE NANOCROSS ELITE BALLOON BURST. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24993455 ↗MalfunctionJan 13, 2026Burst Container or Vessel
IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A PLAQUE LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY USING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AB35W09060080 EVERCROSS 035 BALLOON, A PIN HOLE BALLOON BURST OCCURRED ON THE FIRST INFLATION. 50/50 CONTRAST INFLATION FLUID WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THE BALLOON DID NOT DETACH DURING THE EVENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS ABORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24051792 ↗InjuryDec 18, 2025Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE USING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AB35W07100135 EVERCROSS 035 BALLOON TO POST- DILATE AN 8MM X 7.5CM NON-MEDTRONIC STENT, THE BALLOON RUPTURED AND SUBSEQUENTLY DETACHED FROM THE CATHETER. THE DETACHMENT OCCURRED WHEN TRYING TO REMOVE THE BALLOON AFTER IT BURST. THE DETACHED PORTION OF THE BALLOON BECAME LODGED IN THE RIGHT EXTERNAL ILIAC ART ERY. THE TARGET LESION WAS LOCATED IN THE MID RIGHT COMMON ILIAC ARTERY, CHARACTERIZED BY SEVERE CALCIFICATION, 80% STENOSIS, A LESION LENGTH OF 40MM, AND AN ARTERY DIAMETER OF 8MM. THE VESSEL WAS NOT PRE-DILATED. A 0.035 NON-MEDTRONIC GUIDEWIRE WAS USED. AN INFLATION DEVICE WITH 50/50 CONTRAST INFLATION FLUID WAS USED FOR BALLOON INFLATION. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE DISLODGED BALLOON PORTION. THE BALLOON CATHETER WAS SAFELY REMOVED HOWEVER PART OF THE DETACHED BALLOON REMAINED IN THE VESSEL AND HAD TO BE TACKED TO THE VESSEL WALL WITH AN ADDITIONAL STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23837311 ↗MalfunctionOct 29, 2025Burst Container or Vessel; Burst Container or Vessel
A PATIENT WAS IN INTERVENTIONAL RADIOLOGY FOR A FISTULAGRAM. IT WAS REPORTED THAT WHILE DOING ANGIOPLASTY DURING THE PROCEDURE, THE EVERCROSS BALLOON RUPTURED, POSSIBLY LEAVING FOREIGN BODY IN GRAFT IN LEFT UPPER EXTREMITY. THE PATIENT IS BEING MONITORED AND X-RAYS ORDERED. NO FURTHER PATIENT INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23413229 ↗MalfunctionAug 22, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035 BALLOON TO TREAT A CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY, THE BALLOON BURST ON THE FIRST INFLATION. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22872182 ↗MalfunctionMay 21, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY USING THE EVERCROSS 035 BALLOON, THE DEVICE WOULD NOT FULLY INFLATE DUE TO A KINK CAUSING TWISTING IN THE MIDDLE OF THE BALLOON. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM PACKAGING.THE EVENT OCCURRED AT THE PERIPHERAL ARTERY, SPECIFICALLY THE SUPERFICIAL FEMORAL ARTERY, WITH MINIMAL TORTUOSITY NOTED. THE LESION WAS A SOFT TISSUE LESION. A DOG-BONE TWIST WAS VISIBLE WITHIN THE BALLOON IN THE VESSEL. IT IS NOT KNOWN IF A RE-WRAP TOOL WAS USED. THE VESSEL WAS POST-DILATED USING THE EVERCROSS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DEVICE. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE, WHICH WAS A MEDTRONIC PRODUCT. THERE WERE NO HEALTH CONSEQUENCES OR IMPACT ON THE PATIENT. .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22059945 ↗MalfunctionApr 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT PRIOR TO USE OF THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AB35W08060135 EVERCROSS 035 BALLOON, THERE WERE PACKAGING ISSUES. THE OUTER PACKAGE WAS DAMAGED, AND THERE WAS A TEAR ON THE PACKAGE, WHICH COMPROMISED THE STERILE PACKAGING. THE PROCEDURE INTENDED TO TREAT A CALCIFIED LESION IN THE RIGHT MID COMMON ILIAC ARTERY. THE DEVICE WAS NOT USED IN THE PATIENT, AND A NEW EVERCROSS 8X60X80 DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21907761 ↗MalfunctionApr 4, 2025Material Twisted/Bent; Material Twisted/Bent
PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON DEVICE FOR PATIENT TREATMENT IN THE MID ILIAC ARTERY ¿ COMMON REPORTED TO BE FIBROUS AND EXHIBITING PLAQUE WITH MODERATE TORTUOSITY AND CALCIFICATION WITH 80% STENOSIS. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. BALLOON WAS INFLATED USING A SYRINGE. DEVICE PREPPED AS PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT A KINK/TWIST WAS NOTED AT THE TIP OF THE BALLOON. THE BALLOON WAS USED FOR DILATATION. AFTER THE BALLOON WAS REMOVED, IT WAS FOUND THAT THERE WAS A CREASE AT THE TIP OF THE BALLOON, AND IT COULD NOT BE DILATED NORMALLY. THEN A NEW BALLOON WAS REPLACED AND DILATED NORMALLY. THE NEW BALLOON WAS REPLACED AND DILATED AGAIN, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURY REPORTED FOR THIS EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21771277 ↗MalfunctionApr 1, 2025Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem
IT WAS REPORTED THAT DURING PROCEDURE USING THE EVERCROSS BALLOON, THE PATIENT WAS DIAGNOSED WITH ILIAC ARTERY SCLEROSIS AND OCCLUSION. ANGIOGRAPHY CONFIRMED ILIAC ARTERY STENOSIS WITH 80% LESION STENOSIS IN THE PROXIMAL COMMON ILIAC ARTERY. THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON DILATATION CATHETER WAS USED FOR DILATATION, AND THE BALLOON WAS INFLATED TO THE RATED STANDARD PRESSURE. HOWEVER, THE BALLOON WAS WITHDRAWN AND IT WAS FOUND IT DID NOT DEFLATE WELL. AFTER WITHDRAWING THE BALLOON, BLOOD WAS FOUND INSIDE THE BALLOON, INDICATING A RUPTURE. THE BALLOON WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21741383 ↗MalfunctionMar 14, 2025Burst Container or Vessel; Burst Container or Vessel
A PHYSICIAN WAS USING AN EVERCROSS PTA BALLOON FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY. A 6FR NON-MEDTRONIC SHEATH AND A 0.035 NON-MEDTRONIC GUIDEWIRE WERE USED. THE VESSEL WAS NOT PRE-DILATED. THE BALLOON PASSED THROUGH A PREVIOUSLY DEPLOYED EVERFLEX STENT. NO RESISTANCE WAS MET. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST. IT WAS REPORTED DURING THE SECOND INFLATION THE BALLOON BURST LONGITUDINALLY. IT IS NOT KNOWN AT WHAT PRESSURE THE BALLOON BURST. THE BALLOON DID NOT DETACH AND IT WAS SAFELY REMOVED FROM THE PATIENT. ANOTHER EVERCROSS BALLOON WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21604247 ↗MalfunctionFeb 19, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS PTA BALLOON CATHETER, THERE WERE DEFLATION DIFFICULTIES. THE BALLOON TOOK 10 MINUTES TO FULLY DEFLATE FOR REMOVAL FROM THE POPLITEAL ARTERY. THE LESION WAS LOCATED IN THE MID-SECTION OF THE PERIPHERAL ARTERY WITH A LENGTH OF 60MM AND A DIAMETER OF 5MM, WITH MINIMAL TORTUOSITY AND CALCIFICATION. THE VESSEL WAS POST-DILATED, AND THE BALLOON WAS INFLATED USING A 50/50 CONTRAST FLUID. NEGATIVE PRESSURE WAS APPLIED TO FULLY DEFLATE THE BALLOON, AND AFTER SUFFICIENT TIME, THE DEVICE WAS SUCCESSFULLY WITHDRAWN THROUGH THE SHEATH. NO ISSUES WERE NOTED DURING INFLATION AND NO DAMAGE WAS NOTED TO THE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED USING A NEW EVERCROSS 5X100 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21411421 ↗InjuryFeb 19, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035 BALLOON, THE BALLOON BURST AT 7ATM. A PORTION OF THE BALLOON DETACHED. AN ATTEMPT WAS MADE TO REMOVE THE DETACHED COMPONENT WITH A SNARE BUT IT WAS UNSUCCESSFUL, AND THE DETACHED PORTION REMAINS IN THE PATIENT. THE DETACHED PORTION OF THE DEVICE REMAINS IN THE PATIENT. NO HARM TO THE PATIENT WAS REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21410771 ↗MalfunctionNov 12, 2024Leak/Splash; Leak/Splash
PHYSICIAN ATTEMPTED TO USE AN EVERCROSS 035 PTA BALLOON DURING TREATMENT OF A PLAQUE LESION IN THE PATIENTS RIGHT MID COMMON ILIAC ARTERY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. 50/50 CONTRAST INFLATION FLUID WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. A BALLOON LEAK WAS REPORTED DURING THE PROCEDURE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT WITHOUT INJURY/INTERVENTION. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20663004 ↗MalfunctionNov 7, 2024Burst Container or Vessel; Burst Container or Vessel
AN EVERCROSS PTA BALLOON WAS BEING USED FOR TREATMENT OF A 15-20MM CALCIFIED LESION WITH 95% STENOSIS IN THE MID RIGHT COMMON ILIAC ARTERY. THE ARTERY WAS APPROXIMATELY 7MM IN DIAMETER WITH SEVERE CALCIFICATION AND MODERATE TORTUOSITY. THE IFU WAS FOLLOWED WITHOUT ISSUE. A 6FR NON MEDTRONIC SHEATH AND A 035/260 NON MEDTRONIC GUIDEWIRE WERE USED. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. SEVERE RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. AN UNKNOWN INFLATION DEVICE WAS USED WITH 50/50 CONTRAST INFLATION FLUID. IT WAS REPORTED DURING THE FIRST INFLATION AT 10 ATM THE BALLOON BURST. TYPE OF BALLOON BURST IS NOT KNOWN. THE BALLOON DID NOT DETACH. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A NON MEDTRONIC BALLOON (7MMX20MM) WAS USED TO COMPLETE THE CASE. NO INJURY OR INTERVENTION WAS ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20630128 ↗
Other Ev3, Inc products
All Ev3, Inc devices →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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