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Terminated

Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.

FDA Recall Z-0535-2018 · Posted 2018-01-30

Recalling FirmMedtronic Perfusion Systems
Recall StatusTerminated
Product CodeDWF
Date Initiated2018-01-03
Date Terminated2020-10-05
Product Quantity2914 units

Reason for Recall

Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.

Firm Action

In response to an Urgent Safety Alert issued by Terumo Cardiovascular Systems (CVS) Medtronic initiated their safety alert verbally to their direct consignees on 10/23/2017, providing them with a copy of the Terumo Safety Alert dated 06/27/2017. The firm followed this action with a letter on 1/3/18 in which they stated that the action by Terumo CVS was changed to a recall, and , in response, Medtronic was following up as a recall and requested the products be returned.

Root Cause

Component change control

Distribution Pattern

DE, IA, CA and Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K171308Tubing PackMedtronic, Inc. · 2017-06-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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