Terumo Stent Retractor Recall: Risk of Locking Plates Fracturing
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.
Use caution until it’s fixed
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/63175-terumo-stent-retractor-recall-risk-of-locking-plates-fracturing.
Source Summary by GovInfoNow · govinfonow.com/recall/63175-terumo-stent-retractor-recall-risk-of-locking-plates-fracturing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1367-2021
Cite this page
“Terumo Stent Retractor Recall: Risk of Locking Plates Fracturing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63175-terumo-stent-retractor-recall-risk-of-locking-plates-fracturing. Based on FDA recall #Z-1367-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1367-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
Check for the model T401163 with serial numbers T00393 through T00412. These devices were sold with specific GTIN and catalog numbers.
- Brand
Terumo- Product
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an- Category
Medical device
What to do — step by step
Check Device Serial Number
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.
Contact Manufacturer
Reach out to Terumo Cardiovascular Systems Corporation for further assistance or to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
FDA distribution: “US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Maryland, Nevada, New Hampshire, New Jersey, Pennsylvania, Tennessee, Wisconsin.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1367-2021 (March 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1367-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.