EverCross™ AB35W06200135 (UDI 00643169974012)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169974012), received between Jan 4, 2021 and Feb 1, 2024 — classified as 1 death, 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A EVERCROSS TO TREAT A CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. DEGREE OF TORTUOSITY WAS LITTLE. DEGREE OF CALCIFICATION WAS MODERATE. A 6F DESTINATION SHEATH WAS USED. A .035 STIFF GLIDE GUIDEWIRE WAS USED. EMBOLIC PROTECTION WAS NOT USED. AN INFLATION DEVICE WAS USED. DEVICE WAS PREPPED PER IFU. THERE WAS A LONGITUDINAL BALLOON BURST ON THE FIRST INFLATION AT 8ATMS. AFTER LOADING ONTO THE PRIMARY GUIDEWIRE, THE PHYSICIAN NOTED THAT CONTRAST WAS SEEN EXITING THE BALLOON AFTER THE TECH USED AN INFLATION DEVICE TO TAKE IT TO NOMINAL. AFTER THE BURST BALLOON WAS REMOVED, THE PHYSICIAN ASKED FOR A SECOND 6X200 EVERCROSS TO BE OPENED. AFTER IFU PREP AND INSPECTION, THE PHYSICIAN WAS ABLE TO INFLATE THIS PTA BALLOON TO NOMINAL PRESSURE AND WAS ABLE TO COMPLETE PROCEDURE WITH NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623875 ↗
• InjuryOct 13, 2023Burst 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

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENTS RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION ARE REPORTED. LESION EXHIBITED 90% STENOSIS. EMBOLIC PROTECTION WAS NOT USED. A NON-MEDTRONIC (COOK) INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 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. 50 CONTRAST/ 50 SALINE WAS USED. THE VESSEL WAS PRE-DILATED WITH A 5X120 CHOCOLATE BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. PHYSICIAN BALLOONED THE SFA AND UPON DEFLATION FROM RBP TO 0 THE BALLOON BURST. ISSUE OCCURRED ON FIRST INFLATION. AS THE PHYSICIAN WAS REMOVING THE BALLOON FROM THE CONTRALATERAL SHEATH IN THE GROIN, THE CATHETER THAT THE BALLOON WAS MOUNTED ON BROKE OFF IN THE PATIENT. PHYSICIAN WAS ABLE TO REMOVE BALLOON (FULLY INTACT ON THE CATHETER THAT THE BALLOON IS MOUNTED ON) AND THE CATHETER BY GOING UP THE LEG DISTALLY BY STICKING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17929886 ↗
• DeathMay 12, 2022Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  A PHYSICIAN USED AN EVERCROSS PTA BALLOON DURING TREATMENT OF A CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT'S MID SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL CALCIFICATION IS REPORTED. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT IS REPORTED THE BALLOON BURST AND CAME OFF THE SHAFT OF THE DEVICE. HAEMORRHAGE/BLEED IS REPORTED. DURING THE ATTEMPT TO RETRIEVE THE BALLOON THE ILIAC ARTERY WAS PERFORATED. THE PATIENT IS REPORTED TO BE DECEASED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 14375453 ↗
• InjuryAug 24, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON ALONG WITH A 6FR SHEATH DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS MODERATELY TORTUOUS. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 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. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT DURING BALLOON INFLATION, BALLOON BURST OCCURRED AT 11ATM (RBP). 1 PRIOR INFLATION WAS APPLIED TO THE DEVICE FOR 40 SECONDS PRIOR TO THE ISSUE OCCURRING. PHYSICIAN SNARED THE BALLOON AFTER TWO ATTEMPTS. IT IS REPORTED AORTIC INJURY OCCURRED WHILE SNARING THE BALLOON MATERIAL THAT RUPTURED. VESSEL PERFORATION IS REPORTED. PHYSICIAN CARRIED OUT AAA REPAIRS WITH COVERED STENT DAMAGED AORTA WHICH WAS CAUSED WHILE RETRIEVING THE PTA MATERIAL THAT BROKE OFF. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. NO FURTHER INJURY REPORTED.

  Patient problems: Perforation

  MAUDE report 12357948 ↗
• InjuryFeb 9, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTCA BALLOON TO TREAT A LESION THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY IN A PATIENT. THE LESION WAS FIBROUS, WITH LITTLE TORTUOSITY, AND LITTLE CALCIFICATION. A NON-MEDTRONIC SHEATH WAS USED WITH A NON-MEDTRONIC GUIDEWIRE AND NON-MEDTRONIC. A SPIDER EMBOLIC PROTECTION DEVICE WAS USED. NO DAMAGE WAS NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT A CIRCUMFERENTIAL/RADIAL BALLOON BURST DURING INFLATION AT 14 ATM. THE BALLOON WAS INFLATED IN THE STENT AND IT BURST. THE BALLOON ENCOUNTERED RESISTANCE WHEN REMOVED AND APPEARED TO HAVE PARACHUTED DOWN THE CATHETER. THE CATHETER WAS REMOVED FROM THE PATIENT WITH A PORTION OF THE BALLOON MATERIAL REMAINING ON THE WIRE INSIDE THE PATIENT NEAR THE TIP OF THE SHEATH NOW IN THE LEFT COMMON FEMORAL. THIS WAS THEN ATTEMPTED TO BE REMOVED BY TWO SNARES. SUCCESSFUL REMOVAL OF THE MATERIAL OCCURRED USING A SINGLE USE RADIAL JAW BIOPSY FORCEPS. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. NO FURTHER PATIENT INJURY WAS REPORTED FOR THIS EVENT

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11300844 ↗
• MalfunctionJan 4, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON WITH A 5FR/6FR SHEATH AND 2 NON-MEDTRONIC 0.035 GUIDEWIRES DURING TREATMENT OF A 250MM CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL CALCIFICATION AND TORTUOSITY IS REPORTED. ARTERY DIAMETER REPORTED AS 6MM. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND RESISTANCE WAS NOTED. A CIRCUMFERENTIAL BALLOON BURST IS REPORTED AT NOMINAL PRESSURE (8ATM). NO BALLOON FRAGMENTS REMAINED IN THE PATIENT. A SECOND EVERCROSS PTA BALLOON WAS OPENED AND PREPPED WITHOUT ISSUE. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND RESISTANCE WAS NOTED. A CIRCUMFERENTIAL BALLOON BURST IS REPORTED AT 10ATM. NO BALLOON FRAGMENTS REMAINED IN THE PATIENT. A NON-M EDTRONIC BALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108092 ↗