COBE® Spectra 70700Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05020583707009), received between Aug 17, 2020 and Nov 8, 2024 — classified as 2 deaths, 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A RED BLOOD CELL EXCHANGE (RBCX) AN OPERATOR FOUND AIR BUBBLES IN THE RETURN AIR CHAMBER DURING PRIME ON A COBE SPECTRA DEVICE. THEY STATED THAT THE CHAMBER AIR COULD NOT BE REMOVED FROM THE RETURN SECTION. PER THE CUSTOMER, ALL LUER CONNECTIONS WERE NOT TIGHT, THE BLOOD DIVERSION POUCH WAS NOT INFLATED WITH AIR, NO AIR WAS BEING DRAWN IN THROUGH THE AC LINE OR FILTER, AND THERE WAS NO CLOTTING IN THE SET. THE PATIENT WAS NOT CONNECTED AT THE TIME THEREFORE, NO MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER DECLINED TO PROVIDE PATIENT ID. 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 20641476 ↗
• MalfunctionFeb 28, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event

  THE JOURNAL ARTICLE, 'INTERMEDIATE-DOSE CYCLOPHOSPHAMIDE AND BORTEZOMIB FOR PBSC MOBILIZATION IN MULTIPLE MYELOMA', DESCRIBES A STUDY OF THE MOBILIZATION EFFICACY, SAFETY, AND DISEASE RESPONSE OF INTERMEDIATE-DOSE CYCLOPHOSPHAMIDE (TOTAL 4 G/M2 ) AND BORTEZOMIB (BOR-ID-CY) FOR PBSC MOBILIZATION IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA (MM) WHO HAD UNDERGONE INDUCTION THERAPY, AND COMPARED THESE WITH THE RESPONSES IN A HISTORICAL CONTROL GROUP WHO RECEIVED INTERMEDIATE-DOSE CYCLOPHOSPHAMIDE (ID-CY), WITHOUT BORTEZOMIB, FOR PERIPHERAL BLOOD STEM CELL (PBSC) MOBILIZATION AT THE SAME HOSPITALS. FOUR PATIENTS (19 %) IN THE BOR-ID-CY GROUP AND FOUR PATIENTS (27 %) IN THE ID-CY GROUP DEVELOPED FEBRILE NEUTROPENIA. NINE PATIENTS (43 %) IN THE BOR-ID-CY GROUP AND FOUR PATIENTS (27 %) IN THE ID-CY GROUP NEEDED PLATELET TRANSFUSIONS (TABLE 5). FOUR PATIENTS IN THE BOR-ID-CY GROUP DEVELOPED SEPSIS, AND THE CONFIRMED PATHOGENS WERE: STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS MITIS, STREPTOCOCCUS ORALIS, AND CITROBACTER FREUNDII (N = 1 EACH). NO CASES OF SEPSIS WERE REPORTED IN THE ID-CY GROUP (TABLE 5). THERE WERE NO OTHER SERIOUS NON-HEMATOLOGIC TOXICITIES IN THE TWO GROUPS (TABLE 5), AND N

  Patient problems: Low White Blood Cell Count; No Clinical Signs, Symptoms or Conditions; Sepsis; Thrombocytopenia

  MAUDE report 16454011 ↗
• MalfunctionFeb 21, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; No Apparent Adverse Event

  THE JOURNAL ARTICLE, 'AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR LIVER TRANSPLANT RECIPIENTS WITH RECURRENT PRIMARY SCLEROSING CHOLANGITIS: A PILOT STUDY' DESCRIBES A STUDY WHETHER AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AHSCT) COULD BE USED TO STOP PROGRESSION OF RECURRENT PRIMARY SCLEROSING CHOLANGITIS (PSC) AND PROMOTE OPERATIONAL TOLERANCE AFTER LIVER TRANSPLANTATION. FIVE PATIENTS WITH CLINICAL, BIOCHEMICAL, RADIOLOGIC, AND HISTOLOGIC EVIDENCE OF RECURRENT PSC UNDERWENT AHSCT. AHSC GRAFTS WERE COLLECTED WITH A SINGLE LEUKAPHERESIS PROCEDURE IN ALL 5 PATIENTS. "IN THIS PILOT STUDY OF 5 PATIENTS WHO UNDERWENT AHSCT FOR RECURRENT PSC FOLLOWING LIVER TRANSPLANTATION, 2 ARE ALIVE AND HAVE BEEN OFF IMMUNOSUPPRESSIVE DRUGS WITHOUT EVIDENCE OF PROGRESSION OF PSC OR ALLOGRAFT REJECTION FOR >3 Y, CONSISTENT WITH OPERATIONAL TOLERANCE TO SELF-ANTIGENS AND ALLOANTIGENS. HOWEVER, THE MYELOABLATIVE CONDITIONING REGIMEN (CTX, BUSULFAN, AND ANTITHYMOCYTE GLOBULIN) HAD SIGNIFICANT TOXICITY IN ALL OF THE PATIENTS AND LED TO DEATH OR THE NEED FOR REPEAT LIVER TRANSPLANTATION IN 3 OF THE 5 PATIENTS." THREE OF THE 5 PATIENTS REQUIRED ADMISSION TO AN INTENSIVE CARE UNIT AND

  Patient problems: Heart Failure/Congestive Heart Failure; Liver Failure

  MAUDE report 16414311 ↗
• MalfunctionFeb 21, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE JOURNAL ARTICLE, 'AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR LIVER TRANSPLANT RECIPIENTS WITH RECURRENT PRIMARY SCLEROSING CHOLANGITIS: A PILOT STUDY' DESCRIBES A STUDY WHETHER AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AHSCT) COULD BE USED TO STOP PROGRESSION OF RECURRENT PRIMARY SCLEROSING CHOLANGITIS (PSC) AND PROMOTE OPERATIONAL TOLERANCE AFTER LIVER TRANSPLANTATION. FIVE PATIENTS WITH CLINICAL, BIOCHEMICAL, RADIOLOGIC, AND HISTOLOGIC EVIDENCE OF RECURRENT PSC UNDERWENT AHSCT. AHSC GRAFTS WERE COLLECTED WITH A SINGLE LEUKAPHERESIS PROCEDURE IN ALL 5 PATIENTS. "IN THIS PILOT STUDY OF 5 PATIENTS WHO UNDERWENT AHSCT FOR RECURRENT PSC FOLLOWING LIVER TRANSPLANTATION, 2 ARE ALIVE AND HAVE BEEN OFF IMMUNOSUPPRESSIVE DRUGS WITHOUT EVIDENCE OF PROGRESSION OF PSC OR ALLOGRAFT REJECTION FOR >3 Y, CONSISTENT WITH OPERATIONAL TOLERANCE TO SELF-ANTIGENS AND ALLOANTIGENS. HOWEVER, THE MYELOABLATIVE CONDITIONING REGIMEN (CTX, BUSULFAN, AND ANTITHYMOCYTE GLOBULIN) HAD SIGNIFICANT TOXICITY IN ALL OF THE PATIENTS AND LED TO DEATH OR THE NEED FOR REPEAT LIVER TRANSPLANTATION IN 3 OF THE 5 PATIENTS." THREE OF THE 5 PATIENTS REQUIRED ADMISSION TO AN INTENSIVE CARE UNIT AND

  Patient problems: Heart Failure/Congestive Heart Failure; Liver Failure; Sepsis

  MAUDE report 16414252 ↗
• MalfunctionFeb 21, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE JOURNAL ARTICLE, 'AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR LIVER TRANSPLANT RECIPIENTS WITH RECURRENT PRIMARY SCLEROSING CHOLANGITIS: A PILOT STUDY' DESCRIBES A STUDY WHETHER AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AHSCT) COULD BE USED TO STOP PROGRESSION OF RECURRENT PRIMARY SCLEROSING CHOLANGITIS (PSC) AND PROMOTE OPERATIONAL TOLERANCE AFTER LIVER TRANSPLANTATION. FIVE PATIENTS WITH CLINICAL, BIOCHEMICAL, RADIOLOGIC, AND HISTOLOGIC EVIDENCE OF RECURRENT PSC UNDERWENT AHSCT. AHSC GRAFTS WERE COLLECTED WITH A SINGLE LEUKAPHERESIS PROCEDURE IN ALL 5 PATIENTS. "IN THIS PILOT STUDY OF 5 PATIENTS WHO UNDERWENT AHSCT FOR RECURRENT PSC FOLLOWING LIVER TRANSPLANTATION, 2 ARE ALIVE AND HAVE BEEN OFF IMMUNOSUPPRESSIVE DRUGS WITHOUT EVIDENCE OF PROGRESSION OF PSC OR ALLOGRAFT REJECTION FOR >3 Y, CONSISTENT WITH OPERATIONAL TOLERANCE TO SELF-ANTIGENS AND ALLOANTIGENS. HOWEVER, THE MYELOABLATIVE CONDITIONING REGIMEN (CTX, BUSULFAN, AND ANTITHYMOCYTE GLOBULIN) HAD SIGNIFICANT TOXICITY IN ALL OF THE PATIENTS AND LED TO DEATH OR THE NEED FOR REPEAT LIVER TRANSPLANTATION IN 3 OF THE 5 PATIENTS." THREE OF THE 5 PATIENTS REQUIRED ADMISSION TO AN INTENSIVE CARE UNIT AND

  Patient problems: Heart Failure/Congestive Heart Failure; Liver Failure

  MAUDE report 16414233 ↗
• MalfunctionFeb 21, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE JOURNAL ARTICLE, 'AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR LIVER TRANSPLANT RECIPIENTS WITH RECURRENT PRIMARY SCLEROSING CHOLANGITIS: A PILOT STUDY' DESCRIBES A STUDY WHETHER AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AHSCT) COULD BE USED TO STOP PROGRESSION OF RECURRENT PRIMARY SCLEROSING CHOLANGITIS (PSC) AND PROMOTE OPERATIONAL TOLERANCE AFTER LIVER TRANSPLANTATION. FIVE PATIENTS WITH CLINICAL, BIOCHEMICAL, RADIOLOGIC, AND HISTOLOGIC EVIDENCE OF RECURRENT PSC UNDERWENT AHSCT. AHSC GRAFTS WERE COLLECTED WITH A SINGLE LEUKAPHERESIS PROCEDURE IN ALL 5 PATIENTS. "IN THIS PILOT STUDY OF 5 PATIENTS WHO UNDERWENT AHSCT FOR RECURRENT PSC FOLLOWING LIVER TRANSPLANTATION, 2 ARE ALIVE AND HAVE BEEN OFF IMMUNOSUPPRESSIVE DRUGS WITHOUT EVIDENCE OF PROGRESSION OF PSC OR ALLOGRAFT REJECTION FOR 3 Y, CONSISTENT WITH OPERATIONAL TOLERANCE TO SELF-ANTIGENS AND ALLOANTIGENS. HOWEVER, THE MYELOABLATIVE CONDITIONING REGIMEN (CTX, BUSULFAN, AND ANTITHYMOCYTE GLOBULIN) HAD SIGNIFICANT TOXICITY IN ALL OF THE PATIENTS AND LED TO DEATH OR THE NEED FOR REPEAT LIVER TRANSPLANTATION IN 3 OF THE 5 PATIENTS." PATIENT 2 WAS COMPLETELY WEANED OFF ALL IMMUNOSUPPRESSION BUT DIED AT DAY

  Patient problems: Heart Failure/Congestive Heart Failure; Liver Failure

  MAUDE report 16414131 ↗
• MalfunctionFeb 21, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE JOURNAL ARTICLE, 'AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR LIVER TRANSPLANT RECIPIENTS WITH RECURRENT PRIMARY SCLEROSING CHOLANGITIS: A PILOT STUDY' DESCRIBES A STUDY WHETHER AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AHSCT) COULD BE USED TO STOP PROGRESSION OF RECURRENT PRIMARY SCLEROSING CHOLANGITIS (PSC) AND PROMOTE OPERATIONAL TOLERANCE AFTER LIVER TRANSPLANTATION. FIVE PATIENTS WITH CLINICAL, BIOCHEMICAL, RADIOLOGIC, AND HISTOLOGIC EVIDENCE OF RECURRENT PSC UNDERWENT AHSCT. AHSC GRAFTS WERE COLLECTED WITH A SINGLE LEUKAPHERESIS PROCEDURE IN ALL 5 PATIENTS. "IN THIS PILOT STUDY OF 5 PATIENTS WHO UNDERWENT AHSCT FOR RECURRENT PSC FOLLOWING LIVER TRANSPLANTATION, 2 ARE ALIVE AND HAVE BEEN OFF IMMUNOSUPPRESSIVE DRUGS WITHOUT EVIDENCE OF PROGRESSION OF PSC OR ALLOGRAFT REJECTION FOR >3 Y, CONSISTENT WITH OPERATIONAL TOLERANCE TO SELF-ANTIGENS AND ALLOANTIGENS. HOWEVER, THE MYELOABLATIVE CONDITIONING REGIMEN (CTX, BUSULFAN, AND ANTITHYMOCYTE GLOBULIN) HAD SIGNIFICANT TOXICITY IN ALL OF THE PATIENTS AND LED TO DEATH OR THE NEED FOR REPEAT LIVER TRANSPLANTATION IN 3 OF THE 5 PATIENTS." THREE OF THE 5 PATIENTS REQUIRED ADMISSION TO AN INTENSIVE CARE UNIT AND

  Patient problems: Heart Failure/Congestive Heart Failure; Liver Failure

  MAUDE report 16414006 ↗
• DeathDec 27, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE JOURNAL, 'EFFECTIVENESS AND SAFETY OF LEUKAPHERESIS IN HYPERLEUKOCYTIC LEUKEMIAS: A RETROSPECTIVE MULTICENTER STUDY' DESCRIBES A RETROSPECTIVE STUDY ON LEUKAPHERESIS AMONG 420 PATIENTS WITH ACUTE MYELOID LEUKEMIA (AML), ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) AND CHRONIC MYELOID LEUKEMIA (CML). PER THE ARTICLE THERE WERE ADVERSE EVENTS (AES) SEEN DURING THE STUDY PERIOD. ANEMIA WAS MOST FREQUENT IN AML PATIENTS, WHICH WAS SIGNIFICANTLY HIGHER THAN THAT IN ALL AND CML PATIENTS. THROMBOCYTOPENIA WAS LESS FREQUENT IN CML PATIENTS THAN IN AML PATIENTS AND ALL PATIENTS. THROMBOCYTOPENIA MIGHT DETERIORATE WITH INCREASING CYCLES OF APHERESIS, BUT STATISTICAL SIGNIFICANCE WAS OBSERVED ONLY IN THE AML COHORT. REGARDING THE NONHEMATOLOGICAL AES, 49.76% OF AES WERE RELATED TO SERUM BIOCHEMICAL CHANGES AFTER LEUKAPHERESIS, OF WHICH THE MOST COMMON AES INCLUDED HYPOALBUMINEMIA, INCREASED CREATININE AND HYPOCALCEMIA. ALL AND AML PATIENTS HAD A HIGHER RISK OF COAGULATION DYSFUNCTION, PRESENTING AS DECREASED FIBRINOGEN LEVELS. THERE WAS ALSO A RISK OF APTT PROLONGATION, BUT THERE WAS NO DIFFERENCE AMONG THE THREE COHORTS. THE INCIDENCES OF BLEEDING EVENTS WERE 23.58% IN THE AML COHORT (5 CASES OF S

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16052893 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE JOURNAL ARTICLE, 'NON-CRYOPRESERVED PERIPHERAL BLOOD STEM CELLS AS A SAFE AND EFFECTIVE ALTERNATIVE FOR AUTOLOGOUS TRANSPLANTATION IN MULTIPLE MYELOMA', DESCRIBES A STUDY OF 45 PATIENTS WITH MULTIPLE MYELOMA WHO UNDERWENT AUTOTRANSPLANTATION (17 FRESH PERIPHERAL BLOOD STEM CELLS (PBSC) AND 28 CRYOPRESERVED AUTOLOGOUS STEM CELL) FROM 2017 TO 2021. "WE OBSERVED 47 ADVERSE EVENTS (AES) IN THE STUDY (10 EVENTS IN THE FRESH GROUP VS. 37 EVENTS IN THE CRYOPRESERVED GROUP). AES DURING THE FRESH INFUSION INCLUDED: FEVER (2), VOMITING (1), CHILLS (1), HYPOTENSION (2), HYPERTENSION (1), PARESTHESIA (1), AND DESATURATION (2); WHEREAS IN THE CRYOPRESERVED GROUP THE INFUSION-RELATED EVENTS WERE: COUGHING (5), SORE THROAT (5), NAUSEA (5), VOMITING (5), FLUSHING (3), MALAISE (1), DIZZINESS (1), HYPERTENSION (2), HYPOTENSION (1), DESATURATION (2), HYPOPNEA (1), LOSS OF CONSCIOUSNESS (1), PARESTHESIA (1), CHEST PAIN (1), TACHYCARDIA (1), AND ABDOMINAL PAIN (2). DETAILS REGARDING THE NEED FOR MEDICAL INTERVENTION, IF ANY, WERE NOT PROVIDED IN THE ARTICLE. THE ARTICLE DID NOT PROVIDE SPECIFIC PATIENT INFORMATION, THEREFORE, THIS REPORT IS BEING SUBMITTED AS A SUMMARY OF EVENTS. THE SETS ARE NOT A

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15607113 ↗
• DeathMar 24, 2022Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE JOURNAL ARTICLE "THERAPEUTIC PLASMA EXCHANGE IN MYASTHENIA GRAVIS: A SYSTEMATIC LITERATURE REVIEW AND META-ANALYSIS OF COMPARATIVE EVIDENCE" BY IPE ET AL 2021, A SYSTEMATIC LITERATURE SEARCH WAS PERFORMED FOR STUDIES PUBLISHED BETWEEN 1997 AND 2017 PER PREFERRED REPORTING ITEMS FOR SYSTEMATIC REVIEWS AND META-ANALYSES (PRISMA) GUIDELINES USING TWO DATABASE SOURCES, MEDLINE (THROUGH THE PUBMED DATABASE) AND COCHRANE LIBRARY. THE AUTHORS REPORT ALL-CAUSE MORTALITY DATA FROM SEVERAL STUDIES CAPTURED IN THIS REPORT THAT USED THE SPECTRA SYSTEMS, COBE SPECTRA AND SPECTRA OPTIA APHERESIS SYSTEMS, EXCLUSIVELY (3 ARTICLES) OR AS ONE OF TWO CITED SYSTEMS (2 ARTICLES). ACROSS ALL TREATMENT CONTEXTS IN THE STUDIES USING COBE SPECTRA AND SPECTRA OPTIA APHERESIS SYSTEMS EXCLUSIVELY, 2 DEATHS WERE REPORTED AMONG 284 TREATED PATIENTS. BOTH DEATHS OCCURRED IN PATIENTS DESCRIBED AS HAVING MG-RELATED IMMOBILITY AND WERE SUSPECTED TO HAVE BEEN CAUSED BY CENTRAL VENOUS CATHETER COMPLICATIONS: UROSEPSIS AND PULMONARY EMBOLISM. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND OUTCOME, WERE NOT INCLUDED IN THE ARTICLE FOR THESE EVENTS, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMAR

  Patient problems: Anemia; Hematoma; Low Blood Pressure/ Hypotension; Pulmonary Embolism; Sepsis; Syncope/Fainting

  MAUDE report 13894132 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem

  THIS WAS A RETROSPECTIVE CLINICAL STUDY TO COMPARE SPECTRA OPTIA AND COBE SPECTRA APHERESIS SYSTEMS¿ PERFORMANCE FOR RED BLOOD CELL EXCHANGE PROCEDURES INVOLVING NINETEEN PATIENTS (9 FEMALES WITH AN AVERAGE AGE 25.9, RANGE 20¿39 AND 10 MALES WITH AVERAGE AGE 25.5, RANGE 20¿34). A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE.

  Patient problems: Low Blood Pressure/ Hypotension; Reaction

  MAUDE report 10414786 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem

  THIS WAS A RETROSPECTIVE STUDY TO COMPARE THE EFFICACY AND SIDE EFFECTS OF TWO RED BLOOD CELL EXCHANGE (RBCX) TRANSFUSION SYSTEMS IN SICKLE CELL DISEASE (SCD) FROM (B)(6) 2015 INVOLVING 165 PATIENTS. THERE WERE 59 MALE AND 33 FEMALE PATIENTS WITH AN AGE RANGE OF 29.3 +/- 9.00 YEARS WHO UNDERWENT PROCEDURES ON COBE SPECTRA. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE.

  Patient problems: Reaction

  MAUDE report 10414376 ↗