Enterra ReliaStim Unipolar Lead 30101Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850045965204), received between Aug 27, 2026 and Aug 27, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Break

  Fraying of the Prolene suture - During the procedure, while the surgeon was passing the lead through a 12 mm trocar, he noticed that the needle remained inside the trocar after the lead had entered the abdominal cavity. Upon inspection, the Prolene suture was found to be frayed and had separated from the needle. The trocar was a 12 mm trocar with the backstop removed, and there were no apparent obstructions that could have caught the lead. The surgeon was using the same laparoscopic needle driver and technique that he has routinely used in prior cases to pass the lead sutures/discs through the trocar into the abdominal cavity. No changes had been made to the instruments or technique. The same needle driver was subsequently used to pass the remaining two new leads without any issues. The affected lead was never implanted into the patient. Once the damage was identified, the lead was removed from the sterile field and replaced with a new lead. The replacement lead was implanted successfully without further issues. The patient was not affected by the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50482790 ↗