Terumo Cardiovascular Procedure Kits with High Crack Check Valve Risk of Myocardial Damage
Terumo recalls cardiovascular procedure kits with specific part numbers that may cause pressure relief valve to open at 200-300mmHg instead of 400mmHg, potentially causing myocardial tissue damage requiring surgery.
Use caution until it’s fixed
Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention
Contact the company
What happened, in plain English
Terumo is recalling certain cardiovascular procedure kits that include a High Crack Check Valve (part number 205307A) which may open at 200-300mmHg instead of 400mmHg. This could potentially cause myocardial tissue damage requiring surgical or medical intervention. Read more at govinfonow.com/recall/56136-terumo-cardiovascular-procedure-kits-with-high-crack-check-valve-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/56136-terumo-cardiovascular-procedure-kits-with-high-crack-check-valve-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1401-2024
Cite this page
“Terumo Cardiovascular Procedure Kits with High Crack Check Valve Risk of Myocardial Damage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56136-terumo-cardiovascular-procedure-kits-with-high-crack-check-valve-risk. Based on FDA recall #Z-1401-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1401-2024%22&limit=1).
Why it’s dangerous
The pressure relief valve in these kits is designed to open at 400mmHg, but in some recalled units it opens at 200-300mmHg. This lower pressure threshold could cause the valve to open prematurely during procedures, potentially damaging heart tissue and requiring surgical or medical intervention.
Who’s affected
Healthcare professionals using Terumo cardiovascular procedure kits with specific part numbers (listed in the recall) are most at risk. Patients receiving procedures using these kits may also be affected.
How to tell if you have this one
Check for the High Crack Check Valve part number 205307A in the kit. The affected kits have specific product numbers and part numbers listed in the recall notice, including 6375, 16010, 62974, and other codes.
- Brand
Terumo- Category
Medical device
What to do — step by step
Check Product Details
Review the product numbers and part numbers listed in the recall notice to determine if your kit is affected.
Contact Manufacturer
If you have an affected kit, contact Terumo Cardiovascular Systems Corporation for further instructions.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “worldwide distribution - US Nationwide and the countries of Canada, Chile, Colombia, Mexico, South Korea, Taiwan, Thailand.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 50 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1401-2024 (February 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1401-2024 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.