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Terminated

Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.

FDA Recall Z-1367-2021 · Posted None

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeMWS
Date Initiated2021-03-02
Date Terminated2021-11-05
Product Quantity12

Reason for Recall

There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.

Firm Action

A customer notification letter will be issued on 03/15/2021 by 2-day FedEx mailing to all (8 total) end users who have received affected product. Terumo CVS will provide a replacement device concurrent with the mailing. Customers will be advised to remove the affected product from use and to return product to Terumo CVS using the instructions provided in the customer letter.

Root Cause

Employee error

Distribution Pattern

US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.

Official Source

View FDA Recall →

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

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