TANDEM 71367904Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010481757), received between Oct 29, 2021 and Nov 19, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE INSIDE SNAP RING OF A TANDEM UNI CONV TRL +4MM WAS BROKEN AND WOULD NOT STAY ON THE TRIAL NECK. INCIDENT OCCURRED OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITH A DELAY OF LESS THAN OR EQUAL TO 30 MINUTES, WITH THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844673 ↗
• MalfunctionOct 29, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY THE WHITE RING INSIDE OF A TANDEM UNI CONV TRL +4MM WAS BROKEN AND PARTLY MISSING, IT IS UNKNOWN HOW THIS HAPPENS AND IF THERE ARE PARTS OF THE RING INSIDE OF THE PATIENT. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. THERE WAS A DELAY LESS THAN OR EQUAL TO 30 MINUTES. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719697 ↗