Spectra OptiaRecalls & reported problems across all models
Terumo Bct, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 623
- Deaths reported
- 32
- Injuries reported
- 308
- Recalls
- 0
We found 10 models of Spectra Optia by Terumo Bct, Inc. in the FDA's device registry (GUDID). Together they are named in 623 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2018 and Sep 14, 2026 — classified as 32 deaths, 308 injuries, 283 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (331 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 Spectra Optia problems
Device problems
- Adverse Event Without Identified Device or Use Problem426
- Insufficient Device Problem Information331
- No Apparent Adverse Event95
- Use of Device Problem59
- Improper or Incorrect Procedure or Method19
- Inadequate User Interface15
- Output Problem15
- Device Displays Incorrect Message14
Patient problems
- No Clinical Signs, Symptoms or Conditions182
- Low Blood Pressure/ Hypotension67
- No Known Impact Or Consequence To Patient65
- Reaction50
- Hypersensitivity/Allergic reaction48
- Hemolysis44
- Insufficient Information44
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available31
Spectra Optia models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Spectra Optia® 12220Separator, Automated, Blood Cell, Diagnostic14 deaths147 reports
- Spectra Optia® 10220Separator, Automated, Blood Cell And Plasma, Therapeutic4 deaths127 reports
- Spectra Optia® 12320Separator, automated, blood cell, diagnostic2 deaths119 reports
- Spectra Optia® 10310Separator, automated, blood cell, diagnostic6 deaths103 reports
- Spectra Optia® 61000Separator, automated, blood cell, diagnostic3 deaths49 reports
- Spectra Optia® 10120Separator, automated, blood cell, diagnostic1 death29 reports
- Spectra Optia® 12120Separator, automated, blood cell, diagnostic29 reports
- Spectra Optia® 10110Separator, automated, blood cell, diagnostic2 deaths10 reports
- Spectra Optia® 10300Separator, automated, blood cell, diagnostic9 reports
- Spectra Optia® 11300Bone marrow processing device to support hematopoietic reconstitution1 report
Recent Spectra Optia adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Insufficient Device Problem Information
Patient problems: Hemolysis
MAUDE report 50762831 ↗InjuryAug 28, 2026Insufficient Device Problem Information
Customer reported that after a Therapeutic plasma exchange (TPE) procedure the patient reqiured a platelet transfusion due to a drop in platelet count. Per customer patient status "The patient's condition is unchanged, they are critical ICU level care." The Collection set is not available for return because it was discarded by the customer.
Patient problems: Insufficient Information
MAUDE report 50503148 ↗MalfunctionAug 26, 2026Break; Fluid/Blood Leak
Treatment started at 1300. At 1335 fluid leak detector alarmed indicating fluid in centrifuge area. Treatment paused, centrifuge door opened and noted blood leak. Treatment was terminated with EBL "[estimated blood loss]" 185mL. All component of kit were double checked prior to treatment. Upon inspection all components were properly loaded into the machine. Breakage was noted in tubing distal to hexagon lock. Manufacturer was notified of kit malfunction, and information sent per their request. Optia removed from service for deep cleaning and inspection by HTM "[healthcare technology management]"/vendor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50461860 ↗InjuryAug 25, 2026Insufficient Device Problem Information
Customer reported that after a Continuous Mononuclear Cell Collection (CMNC) the patient's hematocrit dropped from 37% to 25% requiring 2 untis of blood. Per customer patient outcome "Stable before and after procedure. Discharged." The Collection set is not available for return because it was discarded by the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50436013 ↗MalfunctionAug 14, 2026Insufficient Device Problem Information
Patient problems: Hemolysis
MAUDE report 50261925 ↗InjuryAug 14, 2026Insufficient Device Problem Information
The customer reported during the red blood cell depletion of allogeneic bone marrow, an incident occurred involving the OPTIA kit required to perform this type of processing. Specifically, the machine displayed the error message "Overpressure at the ring", and a leak was observed by the operator. The patient was given Prophylactic antibiotic therapy. Due to EU personal data protection laws, the patient information is not available from the customer.
Patient problems: Insufficient Information
MAUDE report 50254978 ↗MalfunctionAug 10, 2026Insufficient Device Problem Information
Customer reported that the product had Staphylococcus epidermidis in all 4 cultures taken after collection. The Collection set is not available for return because it was discarded by the customer.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 50195273 ↗InjuryAug 6, 2026Insufficient Device Problem Information
Customer reported that during a Red Blood Cell Exchange (RBCX) the patient experienced nausea, vomiting, diarrhea and low blood pressure. The procedure was stopped and the patient was given 50mg of IV Benadryl and 0.9% Normal Saline bolus IV. Patient status is stable The Collection set is not available for return because it was discarded by the customer.
Patient problems: Diarrhea; Low Blood Pressure/ Hypotension; Nausea; Vomiting
MAUDE report 50163235 ↗InjuryJul 20, 2026Insufficient Device Problem Information
PER JOURNAL ARTICLE "CENTRIFUGAL TECHNIQUE OF PLASMA EXCHANGE AND LOW-DOSE STEROID TO TREAT VERY SEVERE ALCOHOLIC HEPATITIS PATIENTS: A RETROSPECTIVE ANALYSIS" BY KUMAR, S. E., CHELLAIYA, G. K., SINGH, K. A., KARUPPUSAMI, R., DANIEL, D., DAVID, V. G., NAIR, S. C., VARUGHESE, S., MAMMEN, J., ELIAS, E., EAPEN, C. E., ZACHARIAH, U. G., & GOEL, A. BACKGROUNDLOW-VOLUME PLASMA EXCHANGE (PLEX) AND LOW-DOSE STEROID IMPROVE SURVIVAL IN SEVERE ALCOHOLIC HEPATITIS. WE AIMED TO COMPARE ONE-YEAR SURVIVAL OF VERY SEVERE ALCOHOLIC HEPATITIS (VSAH) PATIENTS TREATED WITH CENTRIFUGAL PLEX (CPLEX), MEMBRANE PLEX (MPLEX) OR STANDARD MEDICAL TREATMENT (SMT).METHODSWE RETROSPECTIVELY ANALYZED SURVIVAL IN CONSECUTIVE VSAH PATIENTS TREATED AT OUR DEPARTMENT FROM NOVEMBER 2017 TO SEPTEMBER 2021. PLEX PATIENTS RECEIVED LOW-VOLUME PLEX ALONG WITH LOW-DOSE STEROID (TAB. PREDNISOLONE 10 MG OR 20 MG DAILY). TO ADJUST FOR BASELINE DIFFERENCES BETWEEN THE THREE TREATMENT (CPLEX, MPLEX OR SMT) GROUPS, PROPENSITY SCORE (PS) MATCHING WAS DONE. ACUTE-ON-CHRONIC LIVER FAILURE (ACLF) WAS DEFINED AS PER EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER (EASL). THE PRIMARY STUDY OUTCOME WAS ONE-YEAR TRANSPLANT-FREE SURVIVA
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25883689 ↗InjuryJul 20, 2026Insufficient Device Problem Information
PER JOURNAL ARTICLE "PLASMA EXCHANGE WITH CORTICOSTEROIDS AS A RESCUE THERAPY FOR SEVERE PROLONGED CHOLESTASIS IN ACUTE VIRAL HEPATITIS" BY TANEJA, S., MEHTANI, R., GANESH, C. P., ROSE, S., BALARAJA, S., KANNUPRIYA, RATHI, S., DE, A., LAMBA, D., VERMA, N., PREMKUMAR, M., HANS, R., SHARMA, R. R., & DUSEJA, A. ABSTRACT: BACKGROUND AND AIMS:PROLONGED CHOLESTASIS AFTER ACUTE VIRAL HEPATITIS (AVH) COMPLICATES <1% OF PATIENTS. THE TREATMENT INCLUDES THE USE OF ANTI-PRURITIC MEDICATIONS IN A STEPWISE MANNER. THIS STUDY ASSESSED THE ROLE OF PLASMA EXCHANGE (PLEX) WITH CORTICOSTEROIDS ON SEVERE PROLONGED CHOLESTASIS.METHODS:RETROSPECTIVE ANALYSIS OF PATIENTS WITH AVH AND PROLONGED CHOLESTASIS WAS CONDUCTED. PROLONGED CHOLESTASIS WAS DEFINED AS JAUNDICE FOR >6 WEEKS WITH PEAK SERUM BILIRUBIN >10 MG/DL, IN THE ABSENCE OF HAEMOLYSIS AND RENAL FAILURE WITH ALANINE TRANSFERASE LEVEL BELOW 500U/L. A COMBINATION OF CENTRIFUGAL PLEX WITH CORTICOSTEROIDS WAS OFFERED IF THERE WAS NO RESPONSE TO ANTI-PRURITIC MEDICATIONS. A CONTROL GROUP, WHICH RECEIVED ONLY ANTI-PRURITIC MEDICATIONS, WAS INCLUDED FOR COMPARISON.RESULTS:FIFTY-NINE PATIENTS, PREDOMINANTLY MALES (90%; N = 53) WERE INCLUDED. MOST COMMON
Patient problems: Adult Respiratory Distress Syndrome
MAUDE report 25883535 ↗InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
CUSTOMER REPORTED HYPOCALCEMIA THAT REQUIRED AN INTRAVENOUS SUBSTITUTION OF IONIZED CA < 1.0 MMOL/L. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. TERUMO BCT IS AWAITING RETURN OF THE COLLECTION SET FOR EVALUATION.
Patient problems: Cramp(s) /Muscle Spasm(s); Hypocalcemia
MAUDE report 25845794 ↗InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
CUSTOMER REPORTED HYPOCALCEMIA ACCOMPANIED BY TETANY THAT REQUIRED AN INTRAVENOUS SUBSTITUTION OF IONIZED CA < 1.0 MMOL/L. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. TERUMO BCT IS AWAITING RETURN OF THE COLLECTION SET FOR EVALUATION.
Patient problems: Cramp(s) /Muscle Spasm(s); Hypocalcemia
MAUDE report 25845678 ↗InjuryJul 16, 2026Insufficient Device Problem Information
PER JOURNAL ARTICLE "PERIPHERAL VENOUS ACCESS FOR LOW-VOLUME CENTRIFUGAL PLASMA EXCHANGE TO TREAT PATIENTS WITH LIVER DISORDERS" BY JANEELA, A. M., CHELLAIYA, G. K., THOMAS, R., BANSAL, A., KUMAR, S., SUNDERRAJ, G., JAYARAMAN, S., KUMAR, S. E., ALEXANDER, V., DAVID, V. G., VARUGHESE, S., DANIEL, D., NAIR, S. C., EAPEN, C. E., GOEL, A., & ZACHARIAH, U. G. BACKGROUND/AIMS: CENTRIFUGAL PLASMA EXCHANGE (PLEX), BY VIRTUE OF LOW BLOOD FLOW RATES, CAN BE PERFORMED VIA PERIPHERAL VENOUS ACCESS. THIS STUDY AIMS TO ASSESS THE UTILIZATION, SAFETY, AND EFFICIENCY OF LOW-VOLUME CENTRIFUGAL PLASMA EXCHANGE VIA PERIPHERAL VENOUS ACCESS (P-PLEX)IN LIVER DISEASE PATIENTS. METHODS: THIS RETROSPECTIVE COHORT STUDY COMPARED PATIENTS WITH LIVER DISEASE WHO UNDERWENT LOW-VOLUME CENTRIFUGAL P-PLEX (2019¿2024) WITH SYNDROME-MATCHED PATIENTS WHO UNDERWENT PLASMA EXCHANGE VIA CENTRAL VENOUS ACCESS (C-PLEX). DATA ON PLEX PROCEDURE, VENOUS ACCESS, AND EXTRACTION EFFICIENCY FOR MOLECULES OF INTEREST WERE NOTED. RESULTS: OF 448 LIVER DISEASE PATIENTS WHO UNDERWENT CENTRIFUGAL LOW-VOLUME PLEX, 81 PATIENTS (18.1%) WHO UNDERWENT P-PLEX (M: 60; AGE: 37 "[29.5¿46.5]" YEARS; MEDIAN, INTERQUARTILE RANGE) WERE COMPARED
Patient problems: Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension; Thrombosis/Thrombus
MAUDE report 25843289 ↗InjuryJul 13, 2026No Apparent Adverse Event; Insufficient Device Problem Information
CUSTOMER REPORTED THAT DURING A THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE THE PATIENT DEVELOPED A SERIOUS REACTION AND HAD TO BE SHIFTED TO THE ICU FOR FURTHER MANAGEMENT. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: Hypersensitivity/Allergic reaction; No Clinical Signs, Symptoms or Conditions
MAUDE report 25804588 ↗InjuryJul 13, 2026No Apparent Adverse Event; Insufficient Device Problem Information
CUSTOMER REPORTED THAT DURING A THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE THE PATIENT DEVELOPED A SERIOUS REACTION AND HAD TO BE SHIFTED TO THE ICU FOR FURTHER MANAGEMENT. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: Hypersensitivity/Allergic reaction; No Clinical Signs, Symptoms or Conditions
MAUDE report 25804444 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page