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.
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
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.
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.
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.
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.
Review the product numbers and part numbers listed in the recall notice to determine if your kit is affected.
If you have an affected kit, contact Terumo Cardiovascular Systems Corporation for further instructions.
The High Crack Check Valve part number 205307A is recalled in certain lots of cardiovascular procedure kits.
The pressure relief valve may open at 200-300mmHg instead of 400mmHg, potentially causing myocardial tissue damage requiring surgical or medical intervention.
Check the product numbers and part numbers listed in the recall notice, including 6375, 16010, 62974, and other codes.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-1401-2024 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-1401-2024 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.
