COBE® Spectra 70400Recalls & reported problems
Terumo Bct, Inc. · Single-Needle Extended Life Platelet Set With LRS® Chamber · Class 2
All models of COBE Spectra (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05020583704008), received between Jun 3, 2020 and Dec 22, 2020 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Bacterial Infection1
- Electrolyte Imbalance1
- Low White Blood Cell Count1
- Nausea1
- Reaction1
- Syncope/Fainting1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem
THIS WAS A RETROSPECTIVE NATIONWIDE COHORT STUDY TO ASSESS THE RISK OF INFECTIONS ASSOCIATED WITH PLATELETPHERESIS DONATIONS USING AN LRS CHAMBER INVOLVING A TOTAL OF 74,408 APHERESIS DONORS IN SWEDEN BETWEEN 1996 AND 2017 (52% MALE, 48% FEMALE WITH A MEAN AGE OF 32.7 YEARS). A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE.
Patient problems: Bacterial Infection; Low White Blood Cell Count; Unspecified Infection
MAUDE report 11057393 ↗InjuryJun 3, 2020Adverse Event Without Identified Device or Use Problem
THIS IS PROSPECTIVE STUDY THAT INCLUDED 1455 PLATELETPHERESIS PROCEDURES PERFORMED ON ELIGIBLE DONORS FROM JULY 2013 TO APRIL 2016. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE.
Patient problems: Electrolyte Imbalance; Nausea; Reaction; Syncope/Fainting
MAUDE report 10114526 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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