Terumo recalls specific stent retractors with potential stainless steel locking plates that could fracture, causing injury during surgery. Affected models include T401163 with serial numbers T00393-T00412.
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
Terumo is recalling stent retractors that may have stainless steel locking plates prone to fracturing during surgery. This could lead to serious injury if the device fails while in use.
The stainless steel locking plates in the stent retractor's mechanism could fracture during use, potentially causing the device to become unstable or fail. This might lead to injury if the device slips or malfunctions during surgery.
Surgical teams using the affected stent retractors during procedures are most at risk. Patients undergoing surgery with these devices could face complications if the locking mechanism fails.
Check for the model T401163 with serial numbers T00393 through T00412. These devices were sold with specific GTIN and catalog numbers.
Look for the serial number on the device, which should be one of T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, or T00412.
Reach out to Terumo Cardiovascular Systems Corporation for further assistance or to confirm if your device is affected.
The recalled device is model T401163 with serial numbers T00393 through T00412.
Check the serial number on your device; if it matches T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, or T00412, it is affected.
Contact Terumo Cardiovascular Systems Corporation to confirm if your device is affected and to get further instructions.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-1367-2021 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-1367-2021 from Terumo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
