Z-1367-2021Class II

Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick...

Name: Z-1367-2021 Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2021-03-02
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2021-03-02 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle... on 2021-03-02. FDA classified it as Class II and gives the reason as "There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1367-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-02
Posted: 2021-04-06
Terminated: 2021-11-05
Recalling firm: Terumo Cardiovascular Systems Corporation
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.
Product code: MWS Stabilizer, Heart
Reason for recall: There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: 12
Distribution: US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.
Product codes and lots: GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1367-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1367-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-14	2021-04-06

Product code MWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)