Lead Adapter 501214Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00821329900280), received between Oct 19, 2018 and Feb 24, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEAD ADAPTER WAS EXPLANTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21451797 ↗
• InjuryNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR SEPTUM (RV) ACCESSORY WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV SEPTUM ACCESSORY REMAINS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 20809085 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THE LEAD ADAPTER WAS EXPLANTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13591185 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THE LEAD ADAPTER WAS CAPPED DUE TO AN INFECTION IN THE PATIENT'S RIGHT FOOT.

  Patient problems: Unspecified Infection

  MAUDE report 11870600 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: THE PATIENTS ENTIRE SYSTEM WAS EXPLANTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11307167 ↗
• InjuryOct 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEE LEADS AND ADAPTER WERE EXPLANTED DUE TO INFECTION/EROSION. THIS IS SIMILAR TO EVENTS MDR 2183787-2019-00091, MDR 2183787-2019-00092, & MDR 2183787-2019-00093.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 9243734 ↗
• InjuryMar 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE AND ADAPTER WERE EXPLANTED AND THE LEAD WAS CAPPED DUE TO INFECTION/SEPSIS. THIS IS A SIMILAR EVENT AS MDR 2183787-2019-00018.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 8390182 ↗
• InjuryFeb 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEAD ADAPTER WAS EXPLANTED DUE TO INFECTION/SEPSIS. LEFT SURGICAL SITE INFECTED FROM WHERE RA AND LV LEADS WERE TUNNELED TO PATIENT'S ABDOMEN. LEADS AND ADAPTERS WERE EXTRACTED AND PORTS WERE PLUGGED ON THE DEVICE. PT DOES STILL HAVE AN RV LEAD THAT WAS TUNNELED FROM THE RIGHT SHOULDER AREA. PG AND RV ARE NOT INFECTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 8335969 ↗
• MalfunctionOct 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: THE EPICARDIAL LEAD WITH THE ADAPTER WAS NOT FUNCTIONING AND THE PHYSICIAN OPTED TO PLACE A TRANSVENOUS LEAD. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS A SIMILAR EVENT AS MDR 2183787-2018-00083.

  Patient problems: No Information

  MAUDE report 7985172 ↗