Consist of a distal connection mechanism (either standard… recallZ-1367-2021 · Terumo Cardiovascular Systems Corporation · initiated Mar 2, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Terumo Cardiovascular Systems Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-1367-2021
- Status
- Terminated
- Initiated by the company
- Mar 2, 2021
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 12
- Product code
- MWS
- Distribution
- US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.
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.
Code information (models, lots, serial numbers)
GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Herc Flex Universal Stabilizer Arm T401163Terumo Cardiovascular Systems Corporation · Stabilizer, Heart1 recall10 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page