Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2021 - (Recall #: Z-1367-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 2, 2021

Date Posted: April 14, 2021

Recall Number: Z-1367-2021

Event ID: 87504

Reason for Recall:

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

Status: Terminated

Product Quantity: 12

Code Information:

GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated