FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: 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.
- Recall number
- Z-1367-2021
- 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.
- Status
- Terminated
- Initiated
- 2021-03-02
- Posted
- not on file
- Terminated
- 2021-11-05
- Reason
- There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
- 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
- 12
- Distribution
- US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.
- Lot, serial or model codes
- GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MWS
- Firm FEI
- 3000204839
- Firm city
- Elkton
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28