EverCrossRecalls & reported problems across all models

We found 17 models of EverCross by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Nov 1, 2024 and Sep 30, 2026 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (15 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

Most reported EverCross problems

EverCross models

17 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EverCross™ AB35W06040135

  Catheter, percutaneous
  2 reports
• EverCross™ AB35W07060135

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• EverCross™ AB35W12020135

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• EverCross™ AB35W05100135

  Catheter, percutaneous
  1 report
• EverCross™ AB35W06040080

  Catheter, angioplasty, peripheral, transluminal
  1 report
• EverCross™ AB35W06060080

  Catheter, percutaneous
  1 report
• EverCross™ AB35W06150135

  Catheter, percutaneous
  1 report
• EverCross™ AB35W07040080

  Catheter, angioplasty, peripheral, transluminal
  1 report
• EverCross™ AB35W07040135

  Catheter, angioplasty, peripheral, transluminal
  1 report
• EverCross™ AB35W07060080

  Catheter, percutaneous
  1 report
• EverCross™ AB35W07100080

  Catheter, percutaneous
  1 report
• EverCross™ AB35W07100135

  Catheter, percutaneous
  1 report
• EverCross™ AB35W08040135

  Catheter, percutaneous
  1 report
• EverCross™ AB35W08060080

  Catheter, percutaneous
  1 report
• EverCross™ AB35W08080135

  Catheter, angioplasty, peripheral, transluminal
  1 report
• EverCross™ AB35W09040080

  Catheter, percutaneous
  1 report
• EverCross™ AB35W10060080

  Catheter, angioplasty, peripheral, transluminal
  1 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 post-dilation of a moderately calcified, minimally tortuous distal right common iliac artery lesion with an 8 mm vessel diameter, an EverCross 035 PTA balloon, burst at 6 atm during the first inflation. The balloon was advanced through a previously deployed EverFlex 8 mm x 100 mm x 80 mm stent over a .035 non Medtronic guidewire and inflated using a non Medtronic inflation device with 50/50 contrast. The instructions for use were followed without issue. The balloon was safely removed without detachment, and a new EverCross 035 PTA balloon, was used. During the first inflation at 6 atm, the second balloon burst. The second balloon was safely removed without detachment, and the physician ended the procedure. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944353 ↗
• MalfunctionSep 30, 2026Burst Container or Vessel

  It was reported that during post-dilation of a moderately calcified, minimally tortuous distal right common iliac artery lesion with an 8 mm vessel diameter, an EverCross 035 PTA balloon, burst at 6 atm during the first inflation. The balloon was advanced through a previously deployed EverFlex 8 mm x 100 mm x 80 mm stent over a .035 non Medtronic guidewire and inflated using a non Medtronic inflation device with 50/50 contrast. The instructions for use were followed without issue. The balloon was safely removed without detachment, and a new EverCross 035 PTA balloon, was used. During the first inflation at 6 atm, the second balloon burst. The second balloon was safely removed without detachment, and the physician ended the procedure. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944325 ↗
• MalfunctionAug 18, 2026Burst Container or Vessel

  It was reported during a procedure using an Evercross PTA balloon catheter for the treatment of a plaque lesion in the distal section of the right and left artery of the distal aorta, the balloon burst "Balloon Burst AT, BELOW, or UNKNOWN Rated Burst Pressure", sp ecifically, a pin hole, which occurred on the first inflation. A 6x45 (Terumo) Destination Sheath was used. Embolic protection was not used. The vessel was not pre or 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 an inflation device and 50/50 contrast 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 event. The device was safely removed from the patient and the procedure was aborted. The patient was reported as alive, with no injury. No health consequences or impact were reported as a result of this event. There was no injury or intervention associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50297095 ↗
• MalfunctionMar 11, 2026Leak/Splash

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035 DEVICE, A LEAK WAS IDENTIFIED AT THE SHAFT OF THE DEVICE. THE PATIENT WAS BEING TREATED FOR A VASCULAR LESION REQUIRING ANGIOPLASTY. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE ISSUE WAS REPORTED AGAINST 2 EVERCROSS DEVICES. 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 24566835 ↗
• MalfunctionMar 11, 2026Leak/Splash

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035 DEVICE, A LEAK WAS IDENTIFIED AT THE SHAFT OF THE DEVICE. THE PATIENT WAS BEING TREATED FOR A VASCULAR LESION REQUIRING ANGIOPLASTY. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE ISSUE WAS REPORTED AGAINST 2 EVERCROSS DEVICES. 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 24566820 ↗
• InjuryFeb 16, 2026Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY EVERCROSS 035, A FISTULA WAS ASSOCIATED WITH THE EVENT. THE BALLOON BURST AT A PRESSURE OF 7 ATM, AND A SURGICAL CUT DOWN INTERVENTION WAS PERFORMED DURING THE PROCEDURE. THE INFLATION FLUID USED WAS A 50/50 CONTRAST MIXTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fistula

  MAUDE report 24343751 ↗
• MalfunctionOct 29, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035 FOR TREATMENT OF A PLAQUE LESION IN THE MID LEFT COMMON ILIAC ARTERY, IT WAS NOTED THAT THE DEVICE WAS MISSING THE PROXIMAL BALLOON MARKER. THE SHEATH USED WAS A 7FR NON-MEDTRONIC SHEATH, AND THE VESSEL WAS BOTH PRE-DILATED WITH AN EVERCROSS 6X40 AND POST-DILATED WITH AN EVERCROSS 7X40. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THE PHYSICIAN PROCEEDED WITHOUT ISSUE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412779 ↗
• MalfunctionSep 2, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035 BALLOON, A PATIENT WITH A SEVERELY CALCIFIED LESION IN THE COMMON ILIAC ARTERY (RIGHT AND LEFT, PROXIMAL AND MID SEGMENTS) EXPERIENCED BALLOON BURST ON FIRST INFLATION AT OR BELOW THE RATED BURST PRESSURE. A 6X11CM NON-MEDTRONIC SHEATH WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST. THE BALLOON BURST OCCURRED WITH TWO SEPARATE EVERCROSS 035 DEVICES. THERE WAS NO INJURY TO THE PATIENT ASSOCIATED WITH THE BALLOON BURST, AND THE DEVICES WERE SAFELY REMOVED FROM THE PATIENT AFTER EACH EVENT. THE PROCEDURE WAS COMPLETED USING A NEW 7X60 EVERCROSS DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932051 ↗
• MalfunctionSep 2, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035 BALLOON, A PATIENT WITH A SEVERELY CALCIFIED LESION IN THE COMMON ILIAC ARTERY (RIGHT AND LEFT, PROXIMAL AND MID SEGMENTS) EXPERIENCED BALLOON BURST ON FIRST INFLATION AT OR BELOW THE RATED BURST PRESSURE. A 6X11CM NON MEDTRONIC SHEATH WAS USED. A NON MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST. THE BALLOON BURST OCCURRED WITH TWO SEPARATE EVERCROSS 035 DEVICES. THERE WAS NO INJURY TO THE PATIENT ASSOCIATED WITH THE BALLOON BURST, AND THE DEVICES WERE SAFELY REMOVED FROM THE PATIENT AFTER EACH EVENT. THE PROCEDURE WAS COMPLETED USING A NEW 7X60 EVERCROSS DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931742 ↗
• MalfunctionJul 7, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT PLAQUE IN THE MID LEFT COMMON ILIAC ARTERY, A BALLOON BURST WITH A PIN HOLE WAS OBSERVED DURING THE FIRST INFLATION OF THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY EVERCROSS PTA BALLOON 035. A NON-MEDTRONIC INFLATION WITH 50/50 CONTRAST WAS USED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, ILLNESSES, INFECTIONS, IRREGULARITIES, OR DEATHS WERE REPORTED. THE PATIENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409949 ↗
• InjuryMay 15, 2025Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  A PATIENT PRESENTED FOR A PLANNED RIGHT LOWER EXTREMITY ANGIOGRAM WITH ANGIOPLASTY. DURING THE PROCEDURE, 2 EVERCROSS PTA BALLOON CATHETERS RUPTURED ON IRREGULAR PLAQUE LEADING TO SEEMING OCCLUSION OF THE DEEP FEMORAL BRANCH. THE FIRST EVERCROSS BALLOON AB35W06060135 HAD A PIN HOLE RUPTURE. THE SECOND EVERCROSS BALLOON AB35W06040135 ALSO HAD REMOVAL DIFFICULTIES. THERE WAS CONCERN FOR POTENTIAL RETAINED BALLOON MATERIAL. THE PROCEDURE WAS ABORTED, AND A VASCULAR SURGEON WAS CONSULTED. THE PATIENT WAS URGENTLY TAKEN TO THE OPERATING ROOM SUITE FOR INTERVENTION. NO BALLOON FRAGMENTS WERE IDENTIFIED. AT THE TIME OF THE BALLOONS RUPTURING, THE INTERVENTIONAL RADIOLOGIST WAS NOT UTILIZING THE INSUFFLATOR AND ONLY USING APPROXIMATELY 8MM HG OF HAND PRESSURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025716 ↗
• MalfunctionMay 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035, THE BALLOON DETACHED WITHIN THE SHEATH. THE DEVICE WAS BEING USED TO TREAT THE VENOUS OUTFLOW OF AN ARTERIOVENOUS FISTULA IN THE LEFT MID VEIN, WHERE A FIBROUS LESION WITH MINIMAL TORTUOSITY AND CALCIFICATION WAS PRESENT. THE LESION HAD A STENOSIS OF 90% AND MEASURED 60 MILLIMETERS IN LENGTH, WITH THE VEIN DIAMETER BEING 8 MILLIMETERS. A 6FR NON MEDTRONIC SHEATH AND A 035 GUIDEWIRE WERE USED. THE VESSEL WAS PRE AND POST DILATED USING EVERCROSS DEVICES. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED EVERFLEX STENT. NO RESISTANCE ENCOUNTERED. A NON MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST. THE DETACHED COMPONENT WAS SAFELY REMOVED WITHIN THE SHEATH, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO INJURY/INTERVENTION ASSOCIATED WITH THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976579 ↗
• InjuryMay 1, 2025Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE TO TREAT A FISTULA IN A PATIENT, AN EVERCROSS 035 PTA BALLOON WAS USED. A NON-MEDTRONIC INFLATION DEVICE AND 50/50 CONTRAST INFLATION FLUID WERE USED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED PROTEGE STENT. DURING THE PROCEDURE, THE BALLOON BURST AND BECAME STUCK ON A STENT STRUT. ISSUE OCCURRED ON FIRST INFLATION. THE BALLOON DID NOT DETACH DURING THE EVENT. THE PHYSICIAN USED A 7X45 NON-MEDTRONIC SHEATH TO ADVANCE A SMALLER BALLOON, WHICH WAS INFLATED INSIDE THE STUCK BALLOON TO DRAG IT OUT OF THE STENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS ULTIMATELY ABORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942109 ↗
• MalfunctionApr 30, 2025Burst Container or Vessel; Burst Container or Vessel

  AN EVERCROSS PTA BALLOON WAS BEING USED FOR TREATMENT OF A CALCIFIED LESION IN THE PROXIMAL REGION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 7FR NON-MEDTRONIC SHEATH AND A 014 NITREX WIRE WERE USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST INFLATION FLUID. IT WAS REPORTED DURING THE FIRST INFLATION A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED. IT IS NOT KNOWN AT WHAT PRESSURE THE BALLOON BURST. THE DEVICE WAS SAFELY REMOVED, THE BALLOON DID NOT DETACH, AND THE PROCEDURE WAS COMPLETED USING ANOTHER EVERCROSS BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933622 ↗
• MalfunctionFeb 13, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY USING THE EVERCROSS 035 A BALLOON DILATATION DEVICE, THE BALLOON GOT STUCK OUTSIDE OF THE 7F SHEATH AND SUBSEQUENTLY RIPPED APART INTO THREE PIECES. THE PROCEDURE WAS BEING PERFORMED AT THE AV ACCESS SITE IN THE RIGHT PROXIMAL VEIN. A 7F SHEATH WAS USED. DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. SEVERE RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. AN INFLATION DEVICE WAS USED. 50/50 CONTRAST WAS USED. THE BALLOON DETACHED WITHIN THE VESSEL, CAUSING REMOVAL DIFFICULTIES. THE DETACHED COMPONENT WAS SUCCESSFULLY REMOVED WITHIN THE SHEATH, AND THE DEVICE WAS REMOVED IN TANDEM WITHOUT INJURY OR INTERVENTION. POST PROCEDURE THE BALLOON WAS DESTROYED. THE SURGERY EXPERIENCED A 15-MINUTE DELAY DUE TO THESE ISSUES. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. THERE WAS NO MEDICATION ADMINISTERED TO THE PATIENT OR ADDITIONAL INTERVENTION REQUIRED IN REMOVING THE DETACHED BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374544 ↗

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