Trima AccelRecalls & reported problems across all models
Terumo Bct, Inc. · 29 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,606
- Deaths reported
- 3
- Injuries reported
- 55
- Recalls
- 0
We found 29 models of Trima Accel by Terumo Bct, Inc. in the FDA's device registry (GUDID). Together they are named in 1,606 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2018 and Sep 29, 2026 — classified as 3 deaths, 55 injuries, 1,548 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (583 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. 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
Reports received per month, all models
Most reported Trima Accel problems
Device problems
- Adverse Event Without Identified Device or Use Problem1,309
- Insufficient Device Problem Information583
- High Test Results262
- High Readings172
- Mechanical Problem132
- Device Slipped120
- Contamination of Device Ingredient or Reagent87
- No Apparent Adverse Event70
Patient problems
- No Clinical Signs, Symptoms or Conditions1,137
- No Patient Involvement416
- No Known Impact Or Consequence To Patient44
- Insufficient Information16
- Reaction13
- Hypersensitivity/Allergic reaction12
- Air Embolism10
- No Consequences Or Impact To Patient9
Trima Accel models
29 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Trima Accel® 82406Separator, automated, blood cell, diagnostic470 reports
- Trima Accel® 82446Separator, automated, blood cell, diagnostic1 death300 reports
- Trima Accel® 81000Separator, automated, blood cell, diagnostic150 reports
- Trima Accel® 80400Separator, automated, blood cell, diagnostic109 reports
- Trima Accel® 80440Separator, automated, blood cell, diagnostic1 death93 reports
- Trima Accel® 82616Separator, automated, blood cell, diagnostic70 reports
- Trima Accel® 82410Separator, automated, blood cell, diagnostic66 reports
- Trima Accel® 80300Separator, automated, blood cell, diagnostic1 death58 reports
- Trima Accel® 82520Separator, automated, blood cell, diagnostic49 reports
- Trima Accel 82656Separator, automated, blood cell, diagnostic44 reports
- Trima Accel® 82440Separator, automated, blood cell, diagnostic40 reports
- Trima Accel® 80360Separator, automated, blood cell, diagnostic24 reports
- Trima Accel® 82300Separator, automated, blood cell, diagnostic16 reports
- Trima Accel® 82416Separator, automated, blood cell, diagnostic14 reports
- Trima Accel® 82470Separator, automated, blood cell, diagnostic13 reports
- Trima Accel® 80410Separator, automated, blood cell, diagnostic12 reports
- Trima Accel® 82400Separator, automated, blood cell, diagnostic12 reports
- Trima Accel® 80370Separator, automated, blood cell, diagnostic11 reports
- Trima Accel® 80406Separator, automated, blood cell, diagnostic10 reports
- Trima Accel® 80350Separator, automated, blood cell, diagnostic8 reports
- Trima Accel® 82666Separator, automated, blood cell, diagnostic8 reports
- Trima Accel® 82700Separator, automated, blood cell, diagnostic7 reports
- Trima Accel® 81002Separator, automated, blood cell, diagnostic5 reports
- Trima Accel® 82660Separator, automated, blood cell, diagnostic5 reports
- Trima Accel® 80520Separator, automated, blood cell, diagnostic4 reports
- Trima Accel® 80340Separator, automated, blood cell, diagnostic3 reports
- Trima Accel® 82408Separator, automated, blood cell, diagnostic3 reports
- Trima Accel® 80500Separator, automated, blood cell, diagnostic1 report
- Trima Accel® 82500Separator, automated, blood cell, diagnostic1 report
Recent Trima Accel adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937692 ↗InjurySep 25, 2026Insufficient Device Problem Information
Customer reported that after the procedure finished the donor fainted and fell after getting off the machine to use the restroom resulting in a serious head injury. The donor was subsequently transferred to a hospital for further medical treatment. Additional follow up confirmed that medical intervention involved the use of hemostatic agents, dehydration therapy, anti-epileptic medications, and nutritional intravenous infusions. The customer declined to provide the Patient Identifier. The Collection set is not available for return because it was discarded by the customer.
Patient problems: Syncope/Fainting
MAUDE report 50897962 ↗MalfunctionFeb 26, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. DONOR UNIT #: (B)(6) THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24457656 ↗MalfunctionFeb 26, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. DONOR UNIT #: (B)(6) THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24457503 ↗MalfunctionFeb 23, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT ID: (B)(6) THE PLATELET COLLECTION IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24421674 ↗MalfunctionFeb 17, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. DONOR UNIT #: (B)(6) THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24367410 ↗MalfunctionFeb 6, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. DONOR UNIT #: (B)(6) THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING; THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279399 ↗MalfunctionFeb 3, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER REPORTED AIR BUBBLES IN THE TUBING LINE DURING THE PRIME OF THE TUBING SET. THE AIR BUBBLES COULD NOT BE REMOVED. DONOR INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE PLATELET COLLECTION IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24247019 ↗MalfunctionJan 29, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. DONOR UNIT#: (B)(6) THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24211086 ↗MalfunctionJan 27, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE UNIT PROCESSING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR ID: (B)(6) THE PLATELET COLLECTION IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24190610 ↗MalfunctionJan 20, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT # (B)(6). THE PLATELET COLLECTION IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24119135 ↗MalfunctionJan 13, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. DONOR UNIT #: (B)(6) THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING; THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24055346 ↗MalfunctionJan 13, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. DONOR UNIT #: (B)(6) THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING; THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24054603 ↗MalfunctionJan 12, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. DONOR UNIT #: (B)(6) THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24039918 ↗MalfunctionJan 6, 2026Defective Component; Insufficient Device Problem Information
THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE OVERFLOW INTO THE PLATELET CONCENTRATE WHEN THE ADDITIVE SOLUTION WAS ADDED. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. NO PATIENT RECEIVED THE PRODUCT AND NO TESTS OF THE PRODUCT WERE MADE AS IT WAS CONTAMINATED WITH RED CELLS AND, THEREFORE, IMMEDIATELY DISCARDED. THE ACTUAL RWBC COUNT CANNOT BE DETERMINED. THE PLATELET COLLECTION IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23976579 ↗
Other Terumo Bct, Inc. products
All Terumo Bct, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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