Siello JT 53Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04035479106249), received between Nov 8, 2019 and Oct 7, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (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.

• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN INFECTION WAS REPORTED, HOWEVER THE DEVICE WAS NOT EXPLANTED. POCKET EROSION WAS ALSO OBSERVED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 12594407 ↗
• MalfunctionAug 26, 2020Failure to Capture; Failure to Capture

  AFTER AN IMPLANTATION PERIOD OF APPROX. 101 MONTHS, IT WAS OBSERVED THAT THERE WAS A LOSS OF CAPTURE ON THE ATRIAL LEAD. THE LEADS WERE CAPPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10457629 ↗
• MalfunctionNov 8, 2019Over-Sensing; Over-Sensing

  APPROXIMATELY 97 MONTHS AFTER IMPLANTATION RIGHT VENTRICULAR OVERSENSING WAS OBSERVED DURING AN IN- OFFICE FOLLOW UP. THE COMPLETE ICD SYSTEM INCLUDING THIS ATRIAL LEAD WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9299808 ↗
• InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS EXPERIENCED A POCKET EROSION WITH THIS SYSTEM.

  Patient problems: Pocket Erosion

  MAUDE report 9298776 ↗