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HARVEST® 51400Recalls & reported problems

Terumo Bct, Inc. · Platelet Concentrate (PC) Procedure Pack, PC-30-01 · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05020583514003), received between Mar 29, 2019 and Feb 14, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Use of Device Problem2
  • Expiration Date Error1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 14, 2020Use of Device Problem; Use of Device Problem

    DURING A CONVERSATION BETWEEN THE TERUMO BCT ACCOUNT MANAGER AND THE DOCTOR AT THE CUSTOMER SITE, THE DOCTOR DISCLOSED THAT THEY PERFORMED A PLATELET-RICH PLASMA (PRP) INJECTION THE PREVIOUS DAY ON A PATIENT WITH CHRONIC FOOT PAIN USING AN EXPIRED SET. IT WAS REPORTED THAT THE DOCTOR KNEW PRIOR TO THE PROCEDURE THAT THE SET WAS EXPIRED AND USED THE SET KNOWINGLY. THE PATIENT STATUS IS REPORTED AS HEALTHY. THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9711753 ↗
  • MalfunctionMar 29, 2019Use of Device Problem; Expiration Date Error; Use of Device Problem

    THE CUSTOMER REPORTED THAT A PC-30 HARVEST SET THAT HAD BEEN EXPIRED FOR APPROXIMATELY 12 YEARS WAS USED WHILE ATTEMPTING TO ISOLATE SOME GROWTH FACTORS. THE SUPPORT SPECIALIST REACH OUT TO THE CUSTOMER AND INSTRUCTED THEM TO STOP USING THE PRODUCT. DURING SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER, THE CUSTOMER CONFIRMED THAT THEY HAD DISPOSED OF THE PRODUCT, THE PATIENT WAS DOING 'FINE' AND THEY ARE PLEASED WITH THE PATIENT'S OUTCOME. THE CUSTOMER DECLINED TO PROVIDE THE PATIENT INFORMATION. THE PC-30 HARVEST SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8464067 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.