—#186201

Product

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 product code: MWS — Stabilizer, Heart
Device class: Class 1
Medical specialty: Cardiovascular
Affected lot / code info: GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412.

Why it was recalled

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

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 125 Blue Ball Rd, Elkton, Maryland 21921-5315

Distribution

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

Timeline

Recall initiated: 2021-03-02
Terminated: 2021-11-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186201. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.