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Haemonetics SQ40SRecalls & reported problems

Haemonetics Corporation · Blood Transfusion Filter · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887691000666), received between Apr 19, 2018 and Apr 19, 2018 — classified as 1 injury.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. Nov 3, 2025Open, Classified

    Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.

    Z-1157-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Reaction1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON MARCH 23 2018 HAEMONETICS RECEIVED A REPORT OF A PATIENT WHO EXPERIENCED TWO POST-TRANSFUSION REACTIONS FOLLOWING CPB AND PROTAMINE ADMINISTRATION DURING A CORONARY ARTERY BYPASS GRAFTING (CABG) SURGICAL PROCEDURE WHILE USING THE HAEMONETICS SQ40¿ BLOOD TRANSFUSION FILTER WHICH HAD OCCURRED ON (B)(6) 2018. THE HOSPITAL REPORTED THAT FOLLOWING EACH REACTION EPISODE THE PATIENT RECEIVED BENADRYL, SOLUMEDROL, EPINEPHRINE, LEVOPHED AND CA++CL-. THE PATIENT ALSO RECEIVED ONE UNITED OF PACKED RED BLOOD CELLS WHILE ON CPB WITHOUT ANY COMPLICATIONS. THE HOSPITAL REPORTED "ULTIMATELY THIS WAS AN ACUTE EVENT AND NO UNTOWARD EFFECTS FOLLOWING INITIAL TREATMENT. PATIENT HOSPITAL COURSE WAS UNEVENTFUL. THE PATIENT MADE A COMPLETE RECOVERY WITHOUT FURTHER SYMPTOMS OR INTERVENTION."

    Patient problems: Reaction

    MAUDE report 7443066 ↗

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.