HARVEST® 51449Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05020583514492), received between Oct 11, 2019 and Oct 11, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 20, 2017Terminated

   Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.

   Z-0075-2018 · Root cause: Packaging · FDA record ↗

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 11, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem

  UPON REVIEW OF THE INFORMATION PROVIDED BY THE DISTRIBUTOR, IT WAS DISCOVERED THAT AN EXPIRED GDP-10 GRAFT DELIVERY SYSTEM DISPOSABLE WAS USED ON A PATIENT. THE GDP-10 DISPOSABLE WAS LABELED WITH AN EXPIRATION DATE OF 09-01-2019 AND THE PROCEDURE WAS PERFORMED ON (B)(6) 2019. THE PRODUCT WAS COLLECTED AND PROCESSED THEN INJECTED BACK TO THE PATIENT. PATIENT INFORMATION AND OUTCOME ARE NOT AVAILABLE AT THIS TIME.THE GDP-10 GRAFT DELIVERY SYSTEM SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9180581 ↗