EverCross™ AB35W05200135 (UDI 00763000184292)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000184292), received between Oct 15, 2020 and Apr 26, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 11, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A EVERCROSS PTA BALLOON DEVICE TO TREAT A LEFT MID/DISTAL SUPERFICIAL FEMORAL ARTERY POPLITEAL ARTERY LESION IN A PATIENT WITH PLAQUE WITH 80% STENOSIS AND LITTLE TORTUOSITY AND SEVERE CALCIFICATION (CTO). THE DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT A BALLOON BURST OCCURRED DURING INFLATION AT THE RATED BURST PRESSURE, ON THE 2ND INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING (SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, NO EXCESSIVE FORCE WAS USED. PROCEDURE WAS COMPLETED WITH BALLOONING, STENTING AND WITH A DRUG ELUTING BALLOON. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11804266 ↗
• MalfunctionOct 15, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE AN EVER-CROSS PTA BALLOON ALONG WITH A NON-MEDTRONIC 7FR SHEATH, A SPIDER 0.014" 320CM GUIDE WIRE AND EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL, MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 150MM RESPECTIVELY. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR THE INFLATION OF THE BALLOON. INFLATION FLUID HEPSAL OMNIPAQUE 60/40 WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP./TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. DURING INITIAL BALLOON INFLATION, BALLOON BURST/LEAK/RUPTURE OCCURRED AT 10AM. ALL FRAGMENTS OF THE BALLOON WAS RETRIEVED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE WITH NO EXCESSIVE FORCE USED. A SECOND EVER-CROSS PTA BALLOON WAS ATTEMPTED, AND DURING INITIAL INFLATION, BALLOON BURST/LEAK/RUPTURE OCCURRED AT 8 AM. PHYSICIAN USED MEDTRONIC 5X150 AND 6X60 PTA BALLOONS, AND STENTS WERE PLACED WITHIN

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10683707 ↗