Lead Adapter 501206Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00821329900266), received between Dec 6, 2017 and Dec 16, 2024 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2024Signal Artifact/Noise; Low impedance; Signal Artifact/Noise; Low impedance

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM EXHIBITED LOW OUT OF RANGE IMPEDANCE MEASUREMENTS AND NOISY SIGNALS FOR ITS RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD HAS BEEN IN SERVICE SINCE 1988. TS WAS CONSULTED AND RECOMMENDED FURTHER IN CLINIC EXAMINATION USING UNIPOLAR SETTING. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT A LATER DATE, THIS RV LEAD WAS CAPPED AND SURGICALLY ABANDONED. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20939534 ↗
• MalfunctionAug 28, 2024Signal Artifact/Noise; Failure to Capture; Signal Artifact/Noise; Failure to Capture

  PACEMAKER SYSTEM HAD A HISTORY OF NOISE ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) CHANNELS, AND THE PATIENT EXPERIENCED DIZZINESS AND BRADYCARDIA. BOTH LEADS WERE ATTACHED TO ADAPTERS IN ORDER TO MOVE THE DEVICE TO THE RIGHT SIDE. LEAD ADAPTER WAS EXPLANTED. THIS EVENT IS RELATED TO 2183787-2024-00060.

  Patient problems: Bradycardia; Dizziness

  MAUDE report 20091882 ↗
• MalfunctionAug 20, 2024Signal Artifact/Noise; Failure to Capture; Signal Artifact/Noise; Failure to Capture

  PACEMAKER SYSTEM HAD A HISTORY OF NOISE ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) CHANNELS, AND THE PATIENT EXPERIENCED DIZZINESS AND BRADYCARDIA. BOTH LEADS WERE ATTACHED TO ADAPTERS IN ORDER TO MOVE THE DEVICE TO THE RIGHT SIDE. LEAD ADAPTER WAS EXPLANTED. THIS EVENT IS RELATED TO 2183787-2024-00061.

  Patient problems: Bradycardia; Dizziness

  MAUDE report 20005347 ↗
• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED LEAD ADAPTER WAS EXPLANTED DUE TO INFECTION. THIS IS A SIMILAR EVENT MDRS 2183787-2021-00109 & 2183787-2021-00110.

  Patient problems: Unspecified Infection

  MAUDE report 13078010 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THE PATIENT WAS SEEN BY A DOCTOR'S OFFICE, WHO STATED THAT THEY SAW LEAD WIRES STICKING OUT OF THE PATIENT. THE PATIENT WAS REFERRED TO A WOUND CENTER AND WAS BEING TREATED. ADDITIONAL FOLLOW-UP ATTEMPTS WERE UNSUCCESSFUL. THE SYSTEM IS CURRENTLY STILL ACTIVE.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 10243021 ↗
• InjuryDec 11, 2019Adverse 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, SEPSIS, AND EROSION.

  Patient problems: Erosion; Sepsis; Unspecified Infection

  MAUDE report 9451053 ↗
• MalfunctionJun 3, 2019Failure to Capture; High impedance; Failure to Capture; High impedance

  AS REPORTED HIGH IMPEDANCE AND NON CAPTURE WERE EXHIBITED WHEN THE LEAD EXTENDERS WERE ATTACHED. THE LEAD WAS CAPPED AND THE ADAPTERS WERE EXPLANTED WERE RETAINED AT THE HOSPITAL AND WILL NOT BE RETURNED. THIS IS A SIMILAR EVENTS MDR 2183787-2019-00046 AND MDR 2183787-2019-00048.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 8663585 ↗
• MalfunctionJun 3, 2019Failure to Capture; High impedance; Failure to Capture; High impedance

  AS REPORTED HIGH IMPEDANCE AND NON CAPTURE WERE EXHIBITED WHEN THE LEAD EXTENDERS WERE ATTACHED. THE LEAD WAS CAPPED AND THE ADAPTERS WERE EXPLANTED WERE RETAINED AT THE HOSPITAL AND WILL NOT BE RETURNED. THIS IS A SIMILAR EVENTS MDR 2183787-2019-00046 AND MDR 2183787-2019-00047.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 8663581 ↗
• InjuryJul 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THE ENTIRE SYSTEM WAS EXPLANTED DUE TO INFECTION. THIS IS THE SAME EVENT AS MDR 2183787-2018-00049.

  Patient problems: Unspecified Infection

  MAUDE report 7682408 ↗
• MalfunctionDec 6, 2017Fracture; Fracture

  AS REPORTED THE PATIENT REQUIRED A CRTP SYSTEM TO BE MOVED FROM (L) PECTORAL REGION TO (R) PECTORAL REGION DUE TO PATIENT REQUIRING RADIOTHERAPY ON THEIR (L) SIDE. THIS INVOLVED TUNNELLING LEADS ACROSS THE CHEST. THE LV LEAD WAS LONG ENOUGH BUT THE ATRIAL AND RV WERE TOO SHORT. AFTER DISCUSSION WITH THE DOCTOR, IT WAS DECIDED TO ATTACH LEAD ADAPTORS TO EACH OF THESE 2 LEADS TO PROVIDE ENOUGH LENGTH TO TAKE THEM FROM (L) TO (R). WHEN ATTEMPTING TO REMOVE THE HEX WRENCH FROM THE SET SCREW OF THE ADAPTER FOR THE ATRIAL LEAD, THE HEX WRENCH BROKE. THE DOCTOR TRIED TO CUT THE HEX WRENCH REMNANTS WITH SCISSORS BUT IN ATTEMPTING TO DO THIS THE PROXIMAL END OF THE LEAD SNAPPED OFF. A NEW ATRIAL LEAD WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7086153 ↗