Adaptor Cable Bipolar 5420Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729982548), received between Oct 4, 2024 and Oct 4, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2024Material Integrity Problem; Material Integrity Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-04963 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HABIB ENDOHPB CABLES WERE USED IN THE BILIARY TO TREAT A TUMOR DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN CONNECTING TO THE ERBE GENERATOR AND THE HABIB ENDOHPB CATHETER, THERE WAS NO ENERGY DELIVERED, AND THERE WAS NO BLANCHING OF THE TISSUE NOTED. SUBSEQUENTLY, UPON TROUBLESHOOTING, IT WAS NOTED THAT THERE WAS NO PROBLEM WITH THE HABIB CATHETER; HOWEVER, THE TWO HABIB CABLES WERE BOTH BROKEN, CAUSING THE HABIB CATHETER TO BE UNABLE TO DELIVER ENERGY. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WILL REPORTEDLY COME BACK AT A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20369892 ↗
• MalfunctionOct 4, 2024Material Integrity Problem; Material Integrity Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT#: 3005099803-2024-04964 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HABIB ENDOHPB CABLES WERE USED IN THE BILIARY TO TREAT A TUMOR DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN CONNECTING TO THE ERBE GENERATOR AND THE HABIB ENDOHPB CATHETER, THERE WAS NO ENERGY DELIVERED, AND THERE WAS NO BLANCHING OF THE TISSUE NOTED. SUBSEQUENTLY, UPON TROUBLESHOOTING, IT WAS NOTED THAT THERE WAS NO PROBLEM WITH THE HABIB CATHETER; HOWEVER, THE TWO HABIB CABLES WERE BOTH BROKEN, CAUSING THE HABIB CATHETER TO BE UNABLE TO DELIVER ENERGY. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WILL REPORTEDLY COME BACK AT A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20369592 ↗