EverCross™ AB35W06200135 (UDI 00763000184513)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000184513), received between Jun 18, 2020 and Apr 14, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2022Burst Container or Vessel; Deflation Problem; Difficult to Remove; Burst Container or Vessel; Deflation Problem; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON ALONG WITH NON-MEDTRONIC 7FR SHEATH AND 0.035" STIFF WIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE LEFT DISTAL COMMON ILIAC ARTERY. THE VESSEL IS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 7MM AND 250MM RESPECTIVELY. THERE WAS NO EMBOLIC PROTECTION USED. A NON-MEDTRONIC INFLATION DEVICE USED. A 1/2 NSS AND 1/2CONTRAST USED FOR INFLATION FLUID. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING BALLOON INFLATION, BALLOON BURST OCCURRED AT 8ATM ON FIRST INFLATION. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. REMOVAL DIFFICULTIES OCCURRED WITH DIFFICULTY REMOVING BALLOON FOLLOWING BALLOON INFLATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT BALLOON WAS PULLED WITH FORCE THROUGH THE SHEATH AFTER RUPTURE. IT WAS EXTREMELY DIFFICULT TO REMOVE DUE TO BALLOON RUPTURING AND NOT COMPLETELY DEFLATING. PHYSICIAN REPORTED EMBOLISM AND THROMBUS WER

  Patient problems: Embolism/Embolus; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 14110061 ↗
• InjurySep 27, 2021Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND A .035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A SEVERE CALCIFIED LESION IN THE PATIENT¿S MID RIGHT PROXIMAL COMMON ILLIAC ARTERY. SLIGHT VESSEL TORTUOSITY IS REPORTED. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. CONTRAST/ SALINE INFLATION FLUID WAS USED. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE AND NO EXCESSIVE FORCE WAS USED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE BALLOON RUPTURED AND SHEARED IN HALF JUST DISTAL TO THE PROXIMAL MARKER WHEN INFLATED TO 10 ATMS. IT IS UNKNOWN WHERE THE BURST OCCURRED. 2 PRIOR INFLATIONS HAD BEEN APPLIED IN THE VESSEL AND THE RUPTURE OCCURRED DURING POST DILATION OF THE STENT. THE BALLOON FRAGMENTED. NO RESISTANCE WAS NOTED WHEN REMOVING THE DEVICE FROM THE PATIENT. THE FRAGMENTED B ALLOON PORTI

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12532082 ↗
• InjuryApr 23, 2021Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON CATHETER DURING PROCEDURE. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE BALLOON SUFFERED RUPTURE AROUND THE CIRCUMFERENCE WHILE BEING INFLATED IN PATIENT. ON ATTEMPTING TO REMOVE IT, THE CATHETER SNAPPED. A LOOP SNARE WAS USED TO GRAP THE BALLOON AND PULL IT OUT THROUGH A SHEATH, AT WHICH POINT THE BALLOON SHEARED OFF THE REMAINS OF THE CATHETER. THE BALLOON WAS THEN SNARED AND REMOVED. THE BALLOON HAD BEEN PREPPED BY FLUSHING THE WIRE CHANNEL WITH HEPARINISED SALINE. IT WAS INFLATED USING A NON-MEDTRONIC INFLATION DEVICE. THE RATED BURST PRESSURE (RBP) WAS NOT EXCEEDED. THE DEVICE HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENTS. THE VESSEL WAS TREATED THE USUAL WAY. THERE WAS NO FURTHER PATIENT INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11716128 ↗
• MalfunctionJan 4, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE A VENASEAL KIT DURING PATIENT TREATMENT. IFU WAS FOLLOWED. IT IS REPORTED DURING PREPARATION OF THE DELIVERY CATHETER THE GUN MALFUNCTIONED AND WOULD NOT ADVANCE. THE PHYSICIAN TROUBLESHOOTED THE ISSUE AND COMPLETED THE CASE BY MANUALLY DELIVERING ADHESIVE BY PUSHING THE PLUNGER. NO PATIENT INJURY REPORTED. PHYSICIAN INTENDED TO USE A VENASEAL KIT DURING TREATMENT OF THE PATIENT¿S GREAT SAPHENOUS VEIN (GSV). THE DEVICE IS REPORTED TO HAVE BEEN DEFECTIVE, BUT THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THE VEIN IS REPORTED TO HAVE CLOSED. NO PATIENT INJURY REPORTED. PHYSICIAN INTENDED TO USE A VENASEAL KIT DURING TREATMENT OF THE PATIENT¿S GREAT SAPHENOUS VEIN (GSV). IT IS REPORTED THE GUN WOULD NOT ENGAGE AND ADHESIVE COULD NOT BE DISPENSED. THE PHYSICIAN PUSHED ON THE BACK OF THE PLUNGER SO THE TEETH WOULD ENGAGE TO COMPLETE THE PROCEDURE USING THIS DEVICE. THE VEIN IS REPORTED TO HAVE CLOSED. NO PATIENT INJURY REPORTED. PHYSICIAN INTENDED TO USE A VENASEAL KIT DURING TREATMENT OF THE PATIENT¿S GREAT SAPHENOUS VEIN (GSV). IT IS REPORTED THE GUN WOULD NOT ENGAGE AND ADHESIVE COULD NOT BE DISPENSED. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE USING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108072 ↗
• InjuryJun 18, 2020Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND NON-MEDTRONIC 0.035 GUIDEWIRE DURING TREATMENT OF A 250MM CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). VESSEL DIAMETER REPORTED AS 6MM. SEVERE VESSEL CALCIFICATION IS REPORTED. NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO SUE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. A NON-MEDTRONIC INFLATION DEVICE AS USED WITH 50/50 CONTRAST AND SALINE MIX. THE DEVICE WAS ADVANCED THROUGH THE 6FR SHEATH FROM CONTRALATERAL ACCESS SITE OVER THE NON-MEDTRONIC 0.035 WIRE TO THE TARGET LEFT SFA LESION. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. THE BALLOON WAS INFLATED ONCE TO DILATE THE LESION AND WAS REMOVED. A STENT WAS THEN PLACED IN THE LEFT SFA. THE EVERCROSS WAS AGAIN ADVANCED TO POST-DILATE THE STENT. IT IS REPORTED THAT THE BALLOON RUPTURED ON SECOND INFLATION AT A PRESSURE OF 8ATM. FOLLOWING THE RUPTURE, THE BALLOON WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE DETACHED FRAGMENTS USING A SNARE UNSUCCESSFULLY. THE PATIENT WAS THEN TRANSFERRED

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10166777 ↗