COBE® Spectra 70610Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05020583706101), received between Apr 24, 2020 and Aug 23, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE, "OPTIMIZED PERIPHERAL BLOOD PROGENITOR CELL MOBILIZATION FOR AUTOLOGOUS HEMATOPOIETIC CELL TRANSPLANTATION IN CHILDREN WITH HIGH-RISK AND REFRACTORY MALIGNANCIES", BY FURLONG, E., JENSEN, J., WOODARD, M., GRIFFITHS, K., KNIGHT, G., STURM, M., KERR, F., GOUGH, H., BEAR, N., CARTER, T. L., COLE, C. H., KOTECHA, R. S., & RAMACHANDRAN, S., A RETROSPECTIVE STUDY OF 125 PEDIATRIC PATIENTS WITH HIGH-RISK MALIGNANCIES UNDERGOING AHSCT IN WESTERN AUSTRALIA BETWEEN 1997 AND 2016 WAS CONDUCTED. MOBILIZATION WAS ACHIEVED BY MEANS OF CHEMOTHERAPY AND GRANULOCYTE COLONY-STIMULATING FACTOR (G-CSF). PATIENTS UNDERWENT APHERESIS THE DAY AFTER CD34+ COUNTS REACHED =20/¿L AND AN ADDITIONAL DOSE OF G-CSF. PERIPHERAL ARTERIAL AND INTRAVENOUS LINES WERE INSERTED IN PEDIATRIC INTENSIVE CARE UNIT UNDER LOCAL ANESTHETIC AND/OR SEDATION, OMITTING THE NEED FOR GENERAL ANESTHESIA AS WELL AS FACILITATING AN UNINTERRUPTED APHERESIS FLOW. LARGER APHERESIS TOTAL BLOOD VOLUMES WERE PROCESSED IN PATIENTS WEIGHING =20 KG. THE MINIMAL DOSE OF =2 × 106 CD34+ CELLS/KG WAS SUCCESSFULLY COLLECTED IN 98.4% OF ALL PATIENTS. THE OPTIMAL DOSE OF 3-5 × 106 CD34+ CELLS/KG WAS COLLECTED IN 96% OF PATIENTS S

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Low Blood Pressure/ Hypotension

  MAUDE report 20054595 ↗
• InjuryJul 30, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "SAFETY OF PERIPHERAL BLOOD STEM CELL HARVEST IN CHILDREN UNDER ANAESTHESIA IN THE DAY CARE SETTING ¿ A SINGLE CENTRE EXPERIENCE" BY DEVASIA, A. J., ABRAHAM, M. A., SAGADEVAN, C., KORULA, A., KULKARNI, U., FOUZIA, N. A., ABRAHAM, A., SRIVASTAVA, A., MATHEWS, V., GEORGE, S. P., GEORGE, B.. POTENTIAL ADVERSE EVENT : BONE AND GENERALIZED BODY PAIN WAS REPORTED BY 35 (22.7%) CHILDREN WHEN THEY RECEIVED G-CSF FOR STEM CELL MOBILIZATION. THESE DONORS WERE GIVEN ORAL ANALGESICS AND THEY COMPLETELY RESPONDED. PAIN WAS NOT REPORTED AFTER G-CSF PRIMING WAS OVER. DURING INSERTION OF THE ACCESS LINE, ONE DONOR DEVELOPED A LOCAL HEMATOMA IN THE FEMORAL REGION, WHILE IN ANOTHER DONOR, THE GUIDE WIRE WAS NOT EASILY NEGOTIATED. NO DONOR DEVELOPED SYMPTOMS RELATED TO HYPOCALCAEMIA DURING THE INFUSION. THE VITAL SIGNS WERE MONITORED WITH NON-INVASIVE DEVICES. SEVEN DONORS DEVELOPED TRANSIENT HYPOTENSION REQUIRING FLUID BOLUSES AND INTERMITTENT DOSES OF EPHEDRINE IN 6 DONORS AND PHENYLEPHRINE IN 1 DONOR. ONE DONOR HAD TRANSIENT BRADYCARDIA WHICH WAS MANAGED SUCCESSFULLY WITH BRONCHODILATORS. RECOVERY FROM SEDATION WAS SMOOTH AND ALL DONORS WERE FULLY AWAKE AT A MEDIAN OF 20 (5 TO

  Patient problems: Bradycardia; Bronchospasm; Fever; Low Blood Pressure/ Hypotension; Pulmonary Edema; Vomiting

  MAUDE report 19864230 ↗
• InjuryDec 20, 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, 'A COMPARISON OF FOUR LEUKAPHERESIS METHODS TO HARVEST AN OPTIMAL DOSE OF CD34+ CELLS: A SINGLE CENTER EXPERIENCE', A RETROSPECTIVE STUDY ANALYZED DATA FOR PATIENTS 18 YEARS AND OLDER WITH HEMATOLOGIC MALIGNANCIES (MULTIPLE MYELOMA (MM), HODGKIN'S LYMPHOMA AND NON-HODGKIN'S LYMPHOMA (NHL)) UNDERGOING AUTOLOGOUS STEM CELL TRANSPLANTATION (ASCT). 116 PATIENTS (78 WITH MM AND 38 WITH NHL) WERE INCLUDED IN THE STUDY GROUP AND 34 PATIENTS (25 WITH MM AND 9 WITH NHL) SERVED AS THE CONTROL GROUP. LEUKAPHERESES WERE PERFORMED USING THE SPECTRA APHERESIS DEVICE. THE LEUKAPHERESIS METHODS USED INCLUDED HIGH VOLUME (HV) LEUKAPHERESIS VERSUS REGULAR VOLUME (RV) WITH OR WITHOUT ANTAGONIST PLERIXAFOR (PX). AMONG ALL HSPC MOBILIZATION AND COLLECTION PROCEDURES, IN 4.4% OF ALL COLLECTIONS, PATIENTS EXPERIENCED SOME DEGREE OF NUMBNESS AND/OR TINGLING OF FINGERS, TOES OR LIPS, WHICH WERE READILY RESOLVED WITH CALCIUM REPLACEMENT (ORALLY OR INTRAVENOUSLY). OVERALL, HV LEUKAPHERESIS GROUP EXPERIENCED RELATIVELY MORE ADVERSE EFFECTS COMPARED TO RV LEUKAPHERESIS, MOST OF WHICH WERE HYPOTENSION AND DIZZINESS (5% VS. 1.9%), PACKED RED BLOOD CELL TRANSFUSION (5% VS. 3.8%) AND PLATELET

  Patient problems: Electrolyte Imbalance; Hypersensitivity/Allergic reaction

  MAUDE report 16017864 ↗
• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem

  THE JOURNAL ARTICLE, 'LEUKAPHERESIS IN 15 PATIENTS WEIGHING 20 KG OR LESS: A SINGLE CENTRE EXPERIENCE', DISCUSSES A STUDY IN WHICH 15 CHILDREN WITH ACUTE LYMPHOBLASTIC LEUKEMIA AND ACUTE MYELOID LEUKEMIA (AML) AND HYPERLEUKOCYTOSIS WERE TREATED WITH THE COBE SPECTRA APHERESIS SYSTEM IN THE GENERAL PEDIATRIC WARD BY THE STAFF FROM THE DEPARTMENT OF BLOOD TRANSFUSION. 26 LEUKAPHERESIS PROCEDURES WERE PERFORMED. 12 PATIENTS (80%) WERE PERFORMED WITH PERIPHERAL VEINS, OTHERS (20%) WITH FEMORAL VEINS. THREE PATIENTS WITH A PLATELET COUNT LESS THAN 20 × 109/L AFTER LEUKAPHERESIS REQUIRED PLATELET TRANSFUSIONS. THERE WAS A 60-DAY MORTALITY RATE OF 13.3% (2 PATIENTS) BY THE END OF THE STUDY. THE TWO PATIENTS EXPIRED WITH SEVERE PULMONARY INFECTIONS. THIS REPORT IS BEING FILED DUE TO PATIENT INJURY/MEDICAL INTERVENTION, THERE IS NO ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE MENTIONED DEATHS. PATIENT INFORMATION IS SUMMARIZED IN THE ARTICLE AS, " FIFTEEN PATIENTS WEIGHING =20 KG WITH DIFFERENT TYPES OF LEUKAEMIA WERE ENROLLED. FIVE OF THE PATIENTS HAD T CELL ACUTE LYMPHOBLASTIC LEUKAEMIA, 5 HAD B CELL ACUTE LYMPHOBLASTIC LEUKAEMIA, 4 HAD ACUTE MYELOGENOUS LEUKAEMIA (MONOCYTIC TY

  Patient problems: Dizziness; Headache; Thrombocytopenia

  MAUDE report 14053478 ↗
• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem

  THE JOURNAL ARTICLE, 'LEUKAPHERESIS IN 15 PATIENTS WEIGHING 20 KG OR LESS: A SINGLE CENTRE EXPERIENCE', DISCUSSES A STUDY IN WHICH 15 CHILDREN WITH ACUTE LYMPHOBLASTIC LEUKEMIA AND ACUTE MYELOID LEUKEMIA (AML) AND HYPERLEUKOCYTOSIS WERE TREATED WITH THE COBE SPECTRA APHERESIS SYSTEM IN THE GENERAL PEDIATRIC WARD BY THE STAFF FROM THE DEPARTMENT OF BLOOD TRANSFUSION. 26 LEUKAPHERESIS PROCEDURES WERE PERFORMED. 12 PATIENTS (80%) WERE PERFORMED WITH PERIPHERAL VEINS, OTHERS (20%) WITH FEMORAL VEINS. THREE PATIENTS WITH A PLATELET COUNT LESS THAN 20 × 109/L AFTER LEUKAPHERESIS REQUIRED PLATELET TRANSFUSIONS. THERE WAS A 60-DAY MORTALITY RATE OF 13.3% (2 PATIENTS) BY THE END OF THE STUDY. THE TWO PATIENTS EXPIRED WITH SEVERE PULMONARY INFECTIONS. THIS REPORT IS BEING FILED DUE TO PATIENT INJURY/MEDICAL INTERVENTION, THERE IS NO ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE MENTIONED DEATHS. PATIENT INFORMATION IS SUMMARIZED IN THE ARTICLE AS, " FIFTEEN PATIENTS WEIGHING =20 KG WITH DIFFERENT TYPES OF LEUKAEMIA WERE ENROLLED. FIVE OF THE PATIENTS HAD T CELL ACUTE LYMPHOBLASTIC LEUKAEMIA, 5 HAD B CELL ACUTE LYMPHOBLASTIC LEUKAEMIA, 4 HAD ACUTE MYELOGENOUS LEUKAEMIA (MONOCYTIC TY

  Patient problems: Dizziness; Headache; Thrombocytopenia

  MAUDE report 14053471 ↗
• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem

  THE JOURNAL ARTICLE, 'LEUKAPHERESIS IN 15 PATIENTS WEIGHING 20 KG OR LESS: A SINGLE CENTRE EXPERIENCE', DISCUSSES A STUDY IN WHICH 15 CHILDREN WITH ACUTE LYMPHOBLASTIC LEUKEMIA AND ACUTE MYELOID LEUKEMIA (AML) AND HYPERLEUKOCYTOSIS WERE TREATED WITH THE COBE SPECTRA APHERESIS SYSTEM IN THE GENERAL PEDIATRIC WARD BY THE STAFF FROM THE DEPARTMENT OF BLOOD TRANSFUSION. 26 LEUKAPHERESIS PROCEDURES WERE PERFORMED. 12 PATIENTS (80%) WERE PERFORMED WITH PERIPHERAL VEINS, OTHERS (20%) WITH FEMORAL VEINS. THREE PATIENTS WITH A PLATELET COUNT LESS THAN 20 × 109/L AFTER LEUKAPHERESIS REQUIRED PLATELET TRANSFUSIONS. THERE WAS A 60-DAY MORTALITY RATE OF 13.3% (2 PATIENTS) BY THE END OF THE STUDY. THE TWO PATIENTS EXPIRED WITH SEVERE PULMONARY INFECTIONS. THIS REPORT IS BEING FILED DUE TO PATIENT INJURY/MEDICAL INTERVENTION, THERE IS NO ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE MENTIONED DEATHS. PATIENT INFORMATION IS SUMMARIZED IN THE ARTICLE AS, " FIFTEEN PATIENTS WEIGHING =20 KG WITH DIFFERENT TYPES OF LEUKAEMIA WERE ENROLLED. FIVE OF THE PATIENTS HAD T CELL ACUTE LYMPHOBLASTIC LEUKAEMIA, 5 HAD B CELL ACUTE LYMPHOBLASTIC LEUKAEMIA, 4 HAD ACUTE MYELOGENOUS LEUKAEMIA (MONOCYTIC TY

  Patient problems: Dizziness; Headache; Thrombocytopenia

  MAUDE report 14053469 ↗
• InjuryAug 18, 2020Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS WAS A RETROSPECTIVE STUDY BETWEEN (B)(6), 2013 AND (B)(6), 2013; A REQUEST FOR PATIENT INFORMATION IS NOT FEASIBLE. THERE WERE A TOTAL OF 26 PATIENTS, 9 FEMALE AND 17 MALES. THE AGE RANGE WAS 23-72 YEARS OLD. THE WEIGHT RANGE WAS 50-148 KG.

  Patient problems: Reaction

  MAUDE report 10421382 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem

  WITHIN THIS ARTICLE, THE ADVERSE EVENTS THAT WERE REGISTERED ON THE COBE SPECTRA WERE THE TWO PATIENTS WITH THROMBOCYTOPENIA AND ONE WITH ANEMIA. THIS IS A RETROSPECTIVE DATA ANALYSIS OF 19 CHILDREN UNDERWENT HPC COLLECTION BETWEEN 2003 AND 2014, 12 BOYS AND 7 GIRLS. THE MEDIAN AGE AT THE LEUKAPHERESIS WAS 5 YEARS OLD (RANGE, <1¿15 YEARS OLD) AND MEDIAN WEIGHT OF 16.8 KG (RANGE, 6.7-42 KG); 17 PATIENTS HAD LESS THAN OR EQUAL TO 30 KG AND THREE OF THEM LESS THAN OR EQUAL TO 10 KG. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE.

  Patient problems: Anemia; Paralysis; Test Result; Toxicity; Vomiting

  MAUDE report 10420244 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem

  PER THE ARTICLE, 'COMPARISON OF TWO APHERESIS SYSTEMS DURING HEMATOPOIETIC PROGENITOR STEM CELL COLLECTIONS AT A TERTIARY MEDICAL CENTER', A RETROSPECTIVE REVIEW OF 41 HEMATOPOIETIC PROGENITOR STEM CELL (HPSC) COLLECTIONS PERFORMED IN 26 SUBJECTS AT A TERTIARY MEDICAL CENTER BETWEEN JUNE 1, 2013, AND DECEMBER 31, 2013, WAS CONDUCTED, 11 WITH THE SPECTRA OPTIA AND 30 WITH THE COBE SPECTRA. SIX PATIENTS UNDERWENT TWO CONSECUTIVE DAILY COLLECTIONS, FIRST ON THE SPECTRA OPTIA FOLLOWED BY THE COBE SPECTRA. SINCE 2013 BOTH APHERESIS SYSTEMS HAVE BEEN USED INTERCHANGEABLY FOR HPSC COLLECTIONS AT THEIR INSTITUTION. THEREFORE, THE GOAL OF THEIR STUDY WAS TO ESTABLISH THE DIFFERENCES BETWEEN THE TWO SYSTEMS DURING HPSC COLLECTIONS TO INCLUDE COLLECTION YIELD, RUN TIME, PLATELET (PLT) LOSSES PER COLLECTION, AND RED BLOOD CELL (RBC) CONTAMINATION OF COLLECTED PRODUCT. SUBJECTS INCLUDING PATIENTS (AUTOLOGOUS DONORS) OR HEALTHY MATCHED-RELATED DONORS (ALLOGENEIC DONORS) WHO WERE REFERRED TO THEIR APHERESIS COLLECTION FACILITY TO UNDERGO HPSC COLLECTIONS BETWEEN JUNE 1, 2013, AND DECEMBER 31, 2013, WERE INCLUDED IN THE STUDY. SOFTWARE USED DURING COLLECTIONS WERE FOR THE COBE SPECTRA VERSIONS 4.7

  Patient problems: Reaction

  MAUDE report 10414471 ↗
• InjuryApr 24, 2020Adverse Event Without Identified Device or Use Problem

  THIS WAS A RETROSPECTIVE CLINICAL STUDY TO EVALUATE THE INCIDENCE OF ADVERSE REACTIONS DURING COLLECTION OF PERIPHERAL BLOOD HEMATOPOIETIC PROGENITOR CELLS IN 1804 AUTOLOGOUS APHERESIS PROCEDURES PERFORMED IN 909 PATIENTS (54,2% MALES, 45,8% FEMALES) WHO WERE MOBILIZED USING CHEMOTHERAPY AND/OR HEMATOPOIETIC GROWTH FACTORS. ALSO, THEY ANALYZED 184 ALLOGENIC APHERESIS PROCEDURES PERFORMED IN 104 HEALTH DONORS (48% MALES, 52% FEMALES). ATTAINMENT OF INDIVIDUAL PATIENT DETAILS IS NOT FEASIBLE.

  Patient problems: Reaction

  MAUDE report 9996285 ↗