Lead Adaptor 666161-302Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885672008277), received between Feb 11, 2021 and Jul 13, 2021 — classified as 4 injuries.

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

• InjuryJul 13, 2021High impedance; Loose or Intermittent Connection; High impedance; Loose or Intermittent Connection

  IT WAS REPORTED THAT WHEN THE DATA OF THE LEAD ITSELF WAS MEASURED AS IT WAS, THE PACING THRESHOLD WAS 2.8V X 0.5MS AND THE RESISTANCE WAS 900?, BUT WHEN IT WAS CONNECTED TO THE 6161 ADAPTER AND MEASURED, THE PACING THRESHOLD WAS OVER 5.0V AND THE RESISTANCE WAS OVER 3000?. ADDITIONALLY, THE CUSTOMER STATED THAT THEY WERE UNABLE TO DETERMINE THE CAUSE OF THE HIGH IMPEDANCES >3000 OHMS AND HIGH THRESHOLDS. WHEN THE LEAD WAS TESTED BY ITSELF, MEASUREMENTS WERE NORMAL, BUT WHEN CONNECTED TO THE ADAPTER, MEASUREMENTS WERE HIGH OUT OF RANGE. IT WAS SUSPECTED THERE WAS A POOR CONNECTION OF THE ADAPTER AND INCOMPLETE FRACTURE OF THE LEAD BUT COULD NOT BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159451 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ADAPTOR UNIV2551 WAS UNABLE TO USE DURING THE PROCEDURE DUE TO UNKNOWN REASON. ADAPTOR UNIV2551 WAS AN ATTEMPTED IMPLANT. THERE WAS SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING DIFFERENT LEADS AND ACCESSORIES. THERE WAS SURGICAL INTERVENTION REPORTED BUT PATIENT OUTCOME IS UNHARMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11975361 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEAD ADAPTORS WERE EXPLANTED BECAUSE OF RIGHT VENTRICULAR LEAD INFECTION. THERE WAS NO KNOWN ISSUE WITH ADAPTOR REPORTED. THE PATIENT'S IMPLANT SITE IS WELL HEALED WITH SWELLING THAT HAS IMPROVED. THERE ARE NO SIGNS OF INFECTION. THE GROIN ACCESS SITE HAS NO BRUISING WITH GOOD PULSE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 11314874 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEAD ADAPTORS WERE EXPLANTED BECAUSE OF RIGHT VENTRICULAR LEAD INFECTION. THERE WAS NO KNOWN ISSUE WITH ADAPTOR REPORTED. THE PATIENT'S IMPLANT SITE IS WELL HEALED WITH SWELLING THAT HAS IMPROVED. THERE ARE NO SIGNS OF INFECTION. THE GROIN ACCESS SITE HAS NO BRUISING WITH GOOD PULSE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 11314804 ↗