HARVESTRecalls & reported problems across all models

We found 5 models of HARVEST by Terumo Bct, Inc. in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Dec 14, 2018 and Feb 16, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (7 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HARVEST recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

Most reported HARVEST problems

HARVEST models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HARVEST® 51449

  Syringe, piston
  1 recall1 report
• HARVEST® 51401

  Platelet and plasma separator for bone graft handling
  3 reports
• HARVEST® 51400

  Platelet and plasma separator for bone graft handling
  2 reports
• HARVEST® 51404

  Platelet and plasma separator for bone graft handling
  1 report
• HARVEST® 51448

  Syringe, piston
  1 report

Recent HARVEST adverse event reports

The 8 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2021Inadequate User Interface; Device Markings/Labelling Problem; Inadequate User Interface

  AFTER MULTIPLE FOLLOW-UP ATTEMPTS, PATIENT INFORMATION, FURTHER PROCEDURAL DETAILS, THE DISPOSITION OF THE COLLECTED PRODUCT AND STATUS OF THE RECIPIENT WERE NOT PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11333513 ↗
• MalfunctionJun 25, 2020Use of Device Problem; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  THE SET WAS BEING USED FOR PLATELET-RICH PLASMA (PRP) FOR THE HAIR RESTORATION PROCEDURE. THE CUSTOMER WAS AWARE THEY WERE USING EXPIRED SETS AND REPLACED THE ACD-A FROM THE SET BEFORE USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10196887 ↗
• MalfunctionJun 25, 2020Use of Device Problem; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  THE SET WAS BEING USED FOR PLATELET-RICH PLASMA (PRP) FOR THE FACIAL. THE CUSTOMER WAS AWARE THEY WERE USING EXPIRED SETS AND REPLACED THE ACD-A FROM THE SET BEFORE USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10196879 ↗
• MalfunctionJun 25, 2020Use of Device Problem; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  THE SET WAS BEING USED FOR PLATELET-RICH PLASMA (PRP) FOR THE KNEE SURGERY. THE CUSTOMER WAS AWARE THEY WERE USING EXPIRED SETS AND REPLACED THE ACD-A FROM THE SET BEFORE USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10196874 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 14, 2018Use of Device Problem; Use of Device Problem; Improper or Incorrect Procedure or Method

  THE CUSTOMER REPORTED THAT AN EXPIRED BONE MARROW ASPIRATE CONCENTRATE (BMAC) DISPOSABLE WAS USED ON A PATIENT. THE BMAC DISPOSABLE WAS LABELED WITH AN EXPIRATION DATE OF (B)(6) 2018. THE PROCEDURE WAS PERFORMED ON (B)(6) 2018. NO ADVERSE EVENTS REPORTED FOR THIS EVENT. THE CUSTOMER DECLINED TO PROVIDE PATIENT INFORMATION. THE BAN-25 8GA BM ASPIRATE NEEDLE IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8166329 ↗

Other Terumo Bct, Inc. products

• Trima Accel29 models · 1,606 reports
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• COBE Spectra6 models · 42 reports