BIS/BIS-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00836559003151), received between Jul 20, 2023 and Jul 12, 2025 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22488392 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE CUSTOMER REPORTED THE IMPLANT DATE OF THE ADAPTOR IS (B)(6) 2023 AND THE EXPLANT DATE IS (B)(6) 2025. THE ADAPTOR WILL BE RETURNED.

  Patient problems: Unspecified Infection

  MAUDE report 22292346 ↗
• MalfunctionJul 20, 2023High impedance; Noise, Audible; High impedance; Noise, Audible

  THE CUSTOMER REPORTED ONCE EXTENDER CONNECTED, ATRIAL SIGNAL NOISY, IMPEDANCE >3000 OHMS. DEVICE NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17362335 ↗