COBE® 2991 90819Recalls & reported problems
Terumo Bct, Inc. · Blood Cell Processing Set · Class 2
Data updated Oct 13, 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 05020583908192), received between Oct 18, 2024 and Oct 18, 2024 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Bacterial Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER REPORTED A MICROBIAL CONTAMINATION IN A BLOOD MARROW PRODUCT AFTER A COLLECTION ON A COBE DEVICE. PER THE CUSTOMER, THE STEM CELL CULTURE WAS POSITIVE FOR GRAM +VE COCCI. THE PRODUCT WAS INFUSED TO A PATIENT. THE PATIENT IS REPORTED TO BE "CLINICALLY STABLE" AND AFEBRILE. FULL DONOR ID: NMDP DONOR GRID# (B)(6) THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: Bacterial Infection
MAUDE report 20482703 ↗
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- Spectra Optia® 10310Terumo Bct, Inc. · Separator, automated, blood cell, diagnostic6 deaths103 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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