EverCross™ AB35W06150135 (UDI 00643169973992)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169973992), received between Mar 24, 2023 and Feb 8, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2024Burst Container or Vessel; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON WITH A 45CM 6FR NON-MEDTRONIC SHEATH DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENTS LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA). LITTLE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTECTION WAS NOT USED. AN 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. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS REPORTED A BALLOON BURST OCCURRED DURING INFLATION AT 10 ATM. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE BUT EXCESSIVE FORCE WAS USED DURING WITHDRAWAL. BALLOON BURST WHEN POST DILATING MULTIPLE STENTS. PHYSICIAN STARTED POST DILATING DISTAL TO PROXIMAL AND SUCCESSFULLY USED A 5MM BALLOON BEFORE THE 6MM BALLOON THAT POPPED WHEN POST DILATING A STENT. PHYSICIAN TRIED TO PULL NEGATIVE MULTIPLE TIMES AFTER IT POPPED AND COULDN'T GET IT TO DEFLATE ENOUGH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667567 ↗
• MalfunctionNov 22, 2023Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND A 45CM NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 25CM CALCIFIED LESION IN THE PATIENTS MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). LITTLE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION ARE REPORTED. LESION EXHIBITED 75% STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. A SPIDER FX EMBOLIC PROTECTION DEVICE WAS USED. A NON-MEDTRONIC 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. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. NO EXCESSIVE FORCE WAS USED. A LONGITUDINAL BALLOON BURST WAS REPORTED DURING BALLOON INFLATION AT 8ATM. BALLOON WAS REMOVED IN ONE PIECE WITH ALL FRAGMENTS STILL PARTIALLY ATTACHED TO THE CATHETER, ALL FRAGMENTS OF THE BALLOON WERE SAFELY REMOVED FROM THE PATIENT. NO VESSEL DAMAGE NOTED. ALTERNATIVE PTA BALLOON ANGIOPLASTY WAS USED TO COMPLETE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192757 ↗
• MalfunctionMar 24, 2023Burst Container or Vessel; Difficult to Remove; Difficult to Advance; Burst Container or Vessel; Difficult to Remove; Difficult to Advance

  A PHYSICIAN WAS USING AN EVERCROSS PTA BALLOON FOR THE TREATMENT OF A CALCIFIED LESION IN THE DISTAL COMMON ILIAC ARTERY. THERE WAS MODERATE TORTUOSITY AND SEVERE CALCIFICATION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. AN UNKNOWN INFLATION DEVICE WAS USED. PHYSICIAN HAD TROUBLE WITH SHEATH TRACKING OVER BIFURCATION AND THROUGH ILIAC. USED A 6MM TO HELP DILATE VESSEL IN ORDER FOR SHEATH TO TRAVEL. IT WAS REPORTED A CIRCUMFERENTIAL/RADIAL BURST OCCURRED WHEN THE BALLOON WAS INFLATED TO NOMINAL PRESSURE. THE DEVICE HAD PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. PHYSICIAN ADVANCED THE BALLOON CATHETER DOWN FURTHER TO HELP GUIDE THE WIRE THROUGH ALREADY DEPLOYED STENTS AND DISEASED VESSEL. THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON CATHETER AND FELT RESISTANCE AND THEN BALLOON JUMPED INTO SHEATH. UPON EXAMINATION IT LOOKED AS IF SOME OF THE BALLOON MATERIAL WAS MISSING FROM THE CATHETER. SHEATHS WERE EXCHANGED AND EXAMINED. ANGIOGRAPHIC IMAGES WERE TAKEN AND MATERIAL COULD NOT BE SEEN OR LOOK TO HAVE DISRUPTED FLOW. DECISION WAS TO LEAVE IT AND PATIENT IS GOING TO HAVE BYPASS SURGERY. DECISION FOR BYPASS SURGERY WAS NOT BASED OFF OF THE BALLOON ISSUE BUT RATH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16613430 ↗