BLV/BIS-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836559006411), received between Apr 25, 2022 and Nov 22, 2024 — classified as 1 death, 1 injury.

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.

• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION 01/23/2025: RE: SN: (B)(6) (PLEASE REFER TO THIS NUMBER IN BODY OF ANY FUTURE CORRESPONDENCE FOR THIS PRODUCT). ON (B)(6) 2024, CRT-D SYSTEM EXTRACTION PERFORMED BY DR. (B)(6), DUE TO INFECTION. LASER LEAD EXTRACTION OF RA, RV, AND LV LEADS. NO PRODUCT PERFORMANCE ISSUES OR COMPLAINTS NOTED AT THE TIME OF EXPLANT. ON (B)(6) 2024, THE DEVICE WAS RECEIVED FROM THE HOSPITAL. THE EVENT DATE IS 08/02/2024. THERE WAS NO PROCEDURE DELAY REPORTED. THE OSCOR ADAPTOR SN: (B)(6) WAS USED TO CONNECT THE LEAD LISTED BELOW TO THREE DIFFERENT ICDS FROM 2011 TO THE 2024 SYSTEM EXPLANT. THE OSCOR ADAPTOR WAS IMPLANTED ON (B)(6) 2011 (BEFORE OUR ICD, DURING THE SAME PROCEDURE THE (B)(6) UNIFY ICD MODEL: CD3231-40, SN: (B)(6), WAS IMPLANTED). PER OUR RECORDS, THE ADAPTOR WAS FOR THE BOSTON SCIENTIFIC LV LEAD: EASYTRAK 2 LV-1 90 CM BOSTON SCIENTIFIC LV LEAD SERIAL NUMBER: (B)(6), MODEL NUMBER: 4518, IMPLANT DATE: ON (B)(6) 2006, EXPLANT DATE: ON (B)(6) 2024. OTHER PRODUCT INFORMATION USED: PRODUCT MODEL: INLICA NEO 7 HF-T DF-1S-1 PROMRI 429553, SERIAL NO. (B)(6), IMPLANT DATE: ON (B)(6) 2024, EXPLANT DATE: ON (B)(6) 2024, THE INTICA NEO 7 HF-T IS AN IMPLANTABLE CARDIAC DEFIBR

  Patient problems: Unspecified Infection

  MAUDE report 20761874 ↗
• DeathApr 25, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT PATIENT DIED DUE TO ACUTE RESPIRATORY FAILURE, COVID-19 AND CONGESTIVE HEART FAILURE. PATIENT DEATH WAS NOT RELATED TO DEVICE MALFUNCTION AND THERE WAS NO DEVICE MALFUNCTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Heart Failure/Congestive Heart Failure; Respiratory Failure

  MAUDE report 14194555 ↗