GAMMA 3525-1440SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252274322), received between Oct 17, 2018 and Oct 17, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (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 16, 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.

• MalfunctionOct 17, 2018Expiration Date Error

  SALES ASSOCIATE OPENED UP EXPIRED IMPLANT. PRODUCT EXPIRED MAY 2018. A COPY OF THAT STICKER WAS PUT ON THE BILLING FORM. IMPLANT WAS GRABBED QUICKLY AND CIRCULATOR WAS NOT IN THE ROOM, SO THE SALES ASSOCIATE OPENED IT UP AT THE DOCTOR¿S REQUEST WITHOUT THOROUGHLY INSPECTING LABEL. THE EXPIRED DEVICE WAS IMPLANTED IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7975327 ↗