BLV/BIS 4403Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00836559009627), received between Mar 15, 2019 and Mar 24, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “High impedance” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2022High impedance; High impedance

  IT WAS REPORTED THAT A REP WAS WITH A PHYSICIAN YESTERDAY ((B)(6)2022) WHO WAS IMPLANTING A 4403 LEAD ADAPTOR (OSCOR MODEL 4403, SERIAL NO. (B)(4)) IN A PATIENT, ADAPTING AN LV (LEFT VENTRICULAR CORONARY SINUS) LEAD TO A PACEMAKER. WHILE IMPLANTING, THE PHYSICIAN EXPERIENCED APPARENTLY ISSUES WITH TIGHTENING THE SETSCREW OF THE LEAD ADAPTOR, HOWEVER IMPLANTED IT APPARENTLY SUCCESSFULLY. HE STATED, THAT THE THRESHOLDS AFTER THE IMPLANT WERE GREAT, LEAD IMPEDANCE NORMAL AT AROUND 500 OHMS, BUT ONCE IN A WHILE JUMPING TO OVER 3000 OHMS. THE PHYSICIAN KEPT THE ADAPTOR IMPLANTED AS IS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13891345 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PER CALL FROM THE FIELD REPRESENTATIVE, THAT SYSTEM WAS INFECTED AND ENTIRE SYSTEM WAS REMOVED (LASER EXTRACTED) TODAY. UNCLEAR IF PATIENT ON IV ANTIBIOTICS. DEVICE WILL BE RETURNED. LEADS WERE USED FOR CULTURES. VERY CLEARLY INFECTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient; Unspecified Infection

  MAUDE report 9540867 ↗
• MalfunctionJun 17, 2019High impedance; High impedance

  THE CUSTOMER REPORTED THE LV (LEFT VENTRICULAR) LEAD HAS A HISTORY OF OUT OF RANGE (OOR) IMPEDANCES. AT THIS TIME THE EVENT IS ASSOCIATED WITH THE LV LEAD, ADAPTOR AND DEVICE. AT THIS TIME ROOT CAUSE IS UNKNOWN, THE OOR IMPEDANCES SEEN ON DAILY MEASUREMENTS TAKEN BY DEVICE. PENDING ROOT CAUSE AND RESOLUTION REGARDING HIGH OOR LV LEAD IMPEDANCES. NO ADVERSE PATIENT EFFECTS REPORTED. THE ADAPTOR REMAINS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8704472 ↗
• InjuryMar 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SYSTEM WAS EXPLANTED BECAUSE OF INFECTION. TEMP WIRE WAS USED. NO OTHER ADVERSE EVENT WAS REPORTED AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8424656 ↗