COBE® Spectra 70500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05020583705005), received between Jun 1, 2020 and Aug 22, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER THE ARTICLE "COMPLICATIONS OF THERAPEUTIC PLASMA EXCHANGE: A RECENT ASSESSMENT" BY DANIEL COURIEL AND ROBERT WEINSTEIN: FOUR PATIENTS (6.4%) EXPERIENCED SEVERE COMPLICATIONS (TABLE VI), ALL OF WHICH WERE RELATED TO THE USE OF VENOUS ACCESS CATHETERS. THESE COMPLICATIONS INCLUDED STAPHYLO COCCAL BACTEREMIA FROM AN INFECTED CATHETER, NECESSITATING AN ADDITIONAL 4 WEEKS OF HOSPITALIZATION FOR ANTIBIOTIC THERAPY, A STERNOCLEIDCIMASTOID HEMATOMA FOLLOWING PLACEMENT OF AN INTERNAL JUGULAR CATHETER, AND AN APICAL PNEUMOTHORAX DURING PLACEMENT OF A SUBCLAVIAN CATHETER. THE LATTER COMPLICATION RESOLVED SPONTANEOUSLY WITHOUT REQUIRING A CHEST TUBE. THE FOURTH SEVERE (CATHETER-RELATED) COMPLICATION OCCURRED IN AN ELDERLY WOMAN WITH MYASTHENIA GRAVIS WHO WAS MALNOURISHED OWING TO SWALLOWING DYSFUNCTION. HER ANTICHOLINESTERASE MEDICATION HAD CAUSED HER TO HAVE CHRONIC DIARRHEA. ON ADMISSION SHE WAS EMACIATED AND MILDLY VITAMIN K DEFICIENT WITH A PROTHROMBIN TIME OF 14 SECONDS (CONTROL 12 SECONDS) AND PLATELET COUNT OF 265 X LO'/LITER. PLACEMENT OF A SUBCLAVIAN CATHETER FOR TPE WAS SEEMINGLY UNEVENTFUL, AND SHE UNDERWENT AN UNCOMPLICATED FIRST TPE FOR 1.5 PLASMA VOLUMES WITH 5% ALBU HER PLAS

  Patient problems: Local Reaction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22879674 ↗
• InjuryAug 22, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER THE JOURNAL ARTICLE, "ADVERSE REACTIONS ASSOCIATED WITH MOBILE THERAPEUTIC APHERESIS:ANALYSIS OF 17,940 PROCEDURES." BY DOBRI D. KIPROV, PATRICIA GOLDEN, REGINA ROHE, SHEILA SMITH, JAN HOFMANN,AND JOHN HUNNICUTT. "ONLY 2 OF 3,583 PATIENTS (0.06%) HAD A FATAL EVENT DURING OR SHORTLY AFTER RECEIVING THERAPEUTIC PLASMAPHERESIS. NEITHER OF THESE DEATHS WERE ATTRIBUTED TO THE USE OF PLASMAPHERESIS." "ADVERSE REACTIONS WERE OBSERVED IN 3.9% (700) OF ALL PROCEDURES. THE FOLLOWING ADVERSE REACTIONS WERE DOCUMENTED: REACTIONS RELATED TO ACD TOXICITY (3%), VASOVAGAL REACTIONS (0.5%), VASCULAR ACCESS RELATED COMPLICATIONS (0.15%), REACTIONS RELATED TO FFP (0.12%), HEPATITIS B FROM FFP (0.06%), ARRHYTHMIAS (0.01%), HEMOLYSIS DUE TO INAPPROPRIATE DILUTION OF 25% ALBUMIN (0.01%), AND ONE DEATH (FROM UNDERLYING DISEASE) DURING A TA PROCEDURE (0.006%) (TABLE II). THE MAJORITY OF ADVERSE REACTIONS WERE MILD OR MODERATE (TABLE III). THE MOST COMMON REACTIONS RELATED TO VASCULAR ACCESS WERE SEEN IN PATIENTS WITH CENTRAL VENOUS CATHETERS (TABLE IV). THE MOST FREQUENT SIDE EFFECT WAS ACD TOXICITY. ACD TOXICITY WAS FOUR TIMES AS FREQUENT IN PATIENTS WITH MYASTHENIA GRAVIS THAN IN PATIENTS WITH OTHER

  Patient problems: Hemolysis; Local Reaction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22879540 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER JOURNAL ARTICLE "USE OF ANGIOTENSIN CONVERTING ENZYME INHIBITORS IN PATIENTS RECEIVING THERAPEUTIC PLASMA EXCHANGE WITH A CENTRIFUGE-BASED APHERESIS SYSTEM" BY JANG, S. M., BAHJRI, K., LEE, J., NABAVI, S., ABDIPOUR, A. ANGIOTENSIN-CONVERTING ENZYME INHIBITORS (ACEI) ARE FREQUENTLY USED ANTIHYPERTENSIVE MEDICATIONS WITH ADDITIONAL ADVANTAGES SUCH AS REDUCING PROTEINURIA AND CARDIOVASCULAR EVENTS. ACEI ARE COMMONLY HELD AT LEAST 24 HOURS BEFORE A THERAPEUTIC PLASMA EXCHANGE (TPE) TO REDUCE POSSIBILITY OF ADVERSE EVENTS (AES) INCLUDING ADVERSE DRUG REACTIONS (ADR). THE OBJECTIVE OF THIS STUDY WAS TO DETERMINE IF ACEI USE INCREASES THE RISK OF ADR IN PATIENTS RECEIVING TPE WITH A CONVENTIONAL CENTRIFUGE-BASED APHERESIS SYSTEM. THIS IS A RETROSPECTIVE CHART REVIEW STUDY (N = 252; 52% MALE). BINARY LOGISTIC REGRESSION WAS USED TO ANALYZE THE ASSOCIATION OF ACEI USE AND AES. OF 171 PATIENTS WHO HAD AE DURING TPE, ONLY 38 PATIENTS WERE TAKING ACEI. THERE WAS NO SIGNIFICANT ASSOCIATION BETWEEN ACEI USE AND AES AFTER ADJUSTMENTS (ODDS RATIO = 0.885, 95% CONFIDENCE INTERVAL: 0.468, 1.674). OUR RESULTS SUGGEST THAT RISK OF AES IS NOT HIGHER IN PATIENTS TAKING ACEI RECEIVING TPE USING A CEN

  Patient problems: Low Blood Pressure/ Hypotension; Rash

  MAUDE report 21027493 ↗
• InjuryJan 7, 2022Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RETROSPECTIVE STUDY "THERAPEUTIC PLASMA EXCHANGE FOR LIFE-THREATENING PEDIATRIC DISORDERS" BY DIANA ET ALL INVESTIGATED ADVERSE EVENTS DURING THERAPEUTIC PLASMA EXCHANGE (TPE) IN PEDIATRICS. TPE WAS PERFORMED ON COBE SPECTRA FOR 731 PROCEDURES (N = 78 PATIENTS; MEAN AGE = 9.8 YR; GENDER = 53.9% MALE). THE AUTHORS REPORTED THAT ¿72 PATIENTS (92%) PRESENT A TOTAL OF 311 AES POTENTIALLY RELATED TO THIS PROCEDURE¿TWENTY-THREE AES (4%) WERE MEDICALLY RELEVANT, WITH A 3 OR HIGHER GRADE ON THE CTCAE SCALE. THE MOST FREQUENTLY RECURRENT AES WERE RELATED TO CITRATE INTOLERANCE (N = 115; 37%) AND LINE OBSTRUCTION (N = 133; 43%). ONLY FIVE (6%) PATIENTS DEVELOPED DOCUMENTED LINE INFECTIONS. TWENTY OF THE AES WERE ALLERGIC REACTIONS (GRADE I: N = 18; GRADE II: N = 1; GRADE III: N = 1), AND OCCURRED IN 14 PATIENTS.¿ THE AUTHORS CONCLUDED ¿THE TPE SESSIONS WERE GENERALLY WELL TOLERATED; MOST OF THE AES OBSERVED IN OUR PEDIATRIC PATIENTS WERE NOT UNEXPECTED AND COULD PERHAPS BE AVOIDED IN THE FUTURE.¿ 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. THE COLLECTION S

  Patient problems: Bacterial Infection; Hypersensitivity/Allergic reaction

  MAUDE report 13192072 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  PER THE JOURNAL ARTICLE: CENTRIFUGAL THERAPEUTIC PLASMA EXCHANGE IN PEDIATRIC PATIENTS BY HANS ET AL, THIS STUDY INVESTIGATED THE SAFETY OF THERAPEUTIC PLASMA EXCHANGE USING COBE SPECTRA, SPECTRA OPTIA, AND CS 3000 PLUS IN PEDIATRIC POPULATIONS. A RETROSPECTIVE ANALYSIS WAS PERFORMED. THERE WERE 672 PROCEDURES IN 99 PEDIATRIC PATIENTS (MEAN AGE = YEARS; MEAN WEIGHT = 20.7 KG). ADVERSE EVENTS OCCURRED IN 5% OF THE PROCEDURES (N = 34). THE FOLLOW ADVERSE EVENTS WERE OBSERVED: ALLERGIC REACTION (2.24%), HYPOTENSION (1%), SYMPTOMATIC HYPOCALCEMIA (1.04%), LINE BLOCKAGE (0.59%), AND FEBRILE NON HEMOLYTIC TRANSFUSION REACTION (0.41%). THE RESULTS ARE PRESENTED IN THE RESULTS SECTION ON PAGE 759 AND IN FIG 1 ON PAGE 760. THE AUTHORS CONCLUDED THAT THERAPEUTIC PLASMA EXCHANGE ¿USING APHERETIC DEVICES BASED ON CENTRIFUGATION IS A SAFE THERAPEUTIC MODALITY IN CHILDREN WHEN PERFORMED WITH ADEQUATE PRECAUTIONS AND UNDER EXPERT TECHNICAL SUPERVISION WITH PROPER SOPS IN PLACE.¿ 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 INT

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

  MAUDE report 12760587 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem

  THE ARTICLE, 'DOUBLE-BLIND, RANDOMIZED CONTROLLED TRIAL OF THERAPEUTIC PLASMA EXCHANGES VS SHAM EXCHANGES IN MODERATE-TO- SEVERE RELAPSES OF MULTIPLE SCLEROSIS' (BROCHET 2019) DESCRIBES A RANDOMIZED CONTROLLED TRIAL THAT COMPARED THERAPEUTIC PLASMA EXCHANGE (TPE) WITH SHAM TREATMENT IN PATIENTS WITH STEROID-RESISTANT, MODERATE-TO- SEVERE MULTIPLE SCLEROSIS RELAPSE BETWEEN 2011 AND 2017. PATIENTS HAD SIX TPE OR SIX SHAM-TPE DURING THE 2 WEEKS AFTER INCLUSION ON COBE SPECTRA PLATFORM. AVERAGE PATIENT AGE WAS 33.5 (RANGE 18 TO 65 YEARS OF AGE) MAJORITY FEMALE (71.5%) FOURTEEN PATIENTS UNDERWENT TPE AND SEVENTEEN UNDERWENT SHAM-TPE WITH EITHER SPECTRA OPTIA OR COBE SPECTRA. 1 PATIENT DEVELOPED A LOCAL HEMATOMA IN THE TPE GROUP. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED. FOUR PATIENTS IN THE SHAM-TPE GROUP EXPERIENCED ADVERSE EVENTS (2 WERE HOSPITALIZED AND 2 EXPERIENCED MS RELAPSES). IT WAS UNCLEAR WHAT PROPORTION OF THESE EVENTS OCCURRED ON COBE SPECTRA/SPECTRA OPTIA. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION, WAS NOT INCLUDED IN THE ARTICLE, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BEC

  Patient problems: Hematoma; Reaction

  MAUDE report 10106861 ↗