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HARVEST® BMAC® 2 51422Recalls & reported problems

Terumo Bct, Inc. · Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-60-01 Procedure Pack · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05020583514225), received between Oct 11, 2022 and Oct 11, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Device problems

  • Insufficient Device Problem Information1
  • Use of Device Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionOct 11, 2022Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

    THE CUSTOMER REPORTED THE USE OF AN EXPIRED HARVEST BMAC SET. PATIENT WEIGHT IS NOT AVAILABLE AT THIS TIME. THE DEVICE WAS USED FOR TREATMENT BUT NOT DIAGNOSIS. THE SET IS NOT AVAILABLE FOR RETURN FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15580293 ↗

Other CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE devices

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Sources and updates

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