Lead Adaptor BIS/BIS-17Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885672008352), received between Feb 23, 2021 and Jun 28, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Ambient Noise Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K010787); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2024High impedance; High Capture Threshold; High impedance; High Capture Threshold

  THE CUSTOMER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WITH A LEAD EXTENSION WAS EXHIBITING HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WITH A LEAD EXTENSION EXHIBITED HIGH THRESHOLDS, HIGH IMPEDANCE AND AN IMPEDANCE SPIKE. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO INJURY NO HARM TO THE PATIENT. BOTH LEADS WITH LEAD EXTENSIONS REMAIN IN USE, NO INTERVENTION COMPLETED. NO INTERVENTION COMPLETED. IMPLANT DATE (B)(6) 2024, REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634579 ↗
• InjuryFeb 23, 2021Ambient Noise Problem; Ambient Noise Problem

  IT WAS REPORTED THE LEAD ADAPTOR WAS SUSPECTED TO BE MALFUNCTIONING DUE TO NOISE. THE ADAPTOR WAS EXPLANTED. NO PATIENT COMPLICATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11367089 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010787. One submission often covers many models, so check the product and lot details in each record.

• Z-2333-2008 · Jan 29, 2008 · Terminated
  Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #: PY244RU, PY252RU, PY258RU, REFINO58RU, RE