EverCross™ AB35W06150135 (UDI 00763000184490)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000184490), received between Oct 1, 2019 and Jan 4, 2021 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 11108062 ↗
• 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-MEDTRONICINFLATION 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 BALLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108044 ↗
• MalfunctionAug 7, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON CATHETER ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.035" GUIDE WIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT MID SUPERFICIAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 150MM RESPECTIVELY. A NON-MEDTRONIC DEVICE WAS USED FOR THE INFLATION OF THE BALLOON. THERE WAS NO DAMAGE TO DEVICE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE BALLOON BURST AT 12ATM DURING BALLOON INFLATION. THE BALLOON WAS REMOVED. ATHERECTOMY WAS PERFORMED AND A NEW BALLOON WAS ADVANCED AND INFLATED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10378586 ↗
• MalfunctionOct 1, 2019Leak/Splash; Leak/Splash

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON CATHETER, ALONG WITH NON MEDTRONIC 6FR SHEATH AND .014 GUIDE WIRE TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT MID TO PROXIMAL SFA. WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL DIAMETER AND LESION LENGTH ARE 7MM AND 200 MM RESPECTIVELY. A NON MEDTRONIC INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. THERE WAS NO DAMAGE NOTED TO PACKAGING OR ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT DURING BALLOON INFLATION A PIN HOLE BALLOON LEAK OCCURRED AT 8ATM. THIS OCCURRED DURING SECOND INFLATION. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A 6 X 120 NANOCROSS BALLOON. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9138825 ↗