COBE® Spectra 70620Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05020583706200), received between Apr 24, 2020 and Feb 25, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Output Problem” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem

  PER THE JOURNAL ARTICLE, "EXTRACORPOREAL PHOTOPHERESIS IN THE MANAGEMENT OF GRAFT VERSUS HOST DISEASE IN CHILDREN¿SINGLE CENTRE EXPERIENCE FROM INDIA" BY VARLA ET AL, IN THIS CONFERENCE ABSTRACT, THE AUTHORS EXPERIENCES WITH EXTRACORPOREAL PHOTOPHERESIS (ECP) IN CHILDREN WAS DESCRIBED. MONONUCLEAR CELLS WERE HARVESTED USING COBE SPECTRA IN 17 PATIENTS (MEDIAN AGE=9 YR, AGE RANGE=2-34). ¿TWO CHILDREN HAD HYPOTENSION DURING ECP... MORTALITY WAS RELATED TO [GRAFT VERSUS HOST DISEASE] GVHD IN 4 CHILDREN AND INFECTION IN 3 CHILDREN.¿ THE AUTHORS CONCLUDED ¿ECP IS A SAFE AND EFFECTIVE SECOND LINE AGENT IN CHILDREN WITH ACUTE GVHD AS IT REDUCES RISK OF VIRAL REACTIVATION ASSOCIATED WITH IMMUNOSUPPRESSIVE THERAPIES.¿ TWO CHILDREN HAD HYPOTENSION DURING ECP AND RESPONDED TO FLUID RESUSCITATION. 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 SUMMARY OF THE EVENTS. IT IS UNKNOWN THAT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THESE EVENTS. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 13601520 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem

  THIS RETROSPECTIVE STUDY WAS TO PRESENT 20 YEARS OF EXPERIENCE WITH APHERESIS COLLECTING OF PERIPHERAL BLOOD STEM CELLS (PBSC) IN DONORS FOR PERIOD FROM 2000 TILL 2020. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE. THERE WERE 71 MALE AND 41 FEMALES, AGED 16-63.

  Patient problems: Numbness

  MAUDE report 11436648 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem

  PATIENT WEIGHT WAS NOT PROVIDED.

  Patient problems: Reaction

  MAUDE report 10109195 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  PATIENT WEIGHT WAS NOT PROVIDED.

  Patient problems: Reaction

  MAUDE report 10109192 ↗
• InjuryApr 24, 2020Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  PER THE ARTICLE, 'PROCEDURE-RELATED COMPLICATIONS AND ADVERSE EVENTS ASSOCIATED WITH PEDIATRIC AUTOLOGOUS PERIPHERAL BLOOD STEM CELL COLLECTION' IN THE JOURNAL OF CLINICAL APHERESIS, A STUDY REGARDING PROCEDURE-RELATED COMPLICATIONS AND ADVERSE EVENTS (AE) ASSOCIATED WITH PEDIATRIC AUTOLOGOUS PERIPHERAL BLOOD HEMATOPOIETIC PROGENITOR (A-HPCC) CELL COLLECTION WAS DESCRIBED. IN TOTAL, 62 CHILDREN UNDERWENT 110 A-HPCC. ALL PROCEDURES WERE PERFORMED WITH COBE SPECTRA USING THE WBC COLLECTION SET. THE STUDY WAS A 4.5 YEAR RETROSPECTIVE REVIEW OF PROSPECTIVELY-COLLECTED, PROCEDURE-RELATED AE DURING HPCC AT THE (B)(6) BETWEEN 4/2009 AND 12/2013. SUMMARY: AE WERE GRADED BY SEVERITY AND TYPE. SIXTY-TWO CHILDREN UNDERWENT 110 A-HPCC, INCLUDING 36 (58%) UNDER 20 KG. FIFTY-FIVE AE WERE DOCUMENTED IN 25.4% A-HPCCS AND 39% OF CHILDREN (CITRATE 25%, ACCESS 19%, TECHNICAL 11%, CARDIOVASCULAR 0%, ALLERGIC 1.8%). NO AE WERE NOTED IN CHILDREN <10 KG ANTICOAGULATED WITH HEPARIN. ACCESS AND TECHNICAL AE ACCOUNTED FOR 73% OF SEVERE AE, WITH LINE-RELATED PROBLEMS UNDERLYING MOST TECHNICAL AE (87.5%, P=0.006). AE WERE MORE LIKELY IN OLDER (P=0.012), HEAVIER PATIENTS (P=0.02), WHO FREQUENTLY REQUIRED MORE

  Patient problems: Reaction

  MAUDE report 9995989 ↗