Medtronic recalls Simulus 750 Flexible Ring/Band Accessory Kit due to potential contact with non-human tissue during use in cardiac procedures.
Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.
Medtronic is recalling its Simulus 750 Flexible Ring/Band Accessory Kit used in cardiac procedures. The recall is because demonstration kits might have been contaminated with porcine tissue, which could pose a risk to patients during surgery.
The demonstration kits, intended for use in wet labs, might have come into contact with porcine (pig) tissue. This could lead to potential cross-contamination during surgical procedures if the kit is used on patients.
Healthcare professionals using the kit for cardiac procedures are most at risk. Patients undergoing surgery with this kit could potentially be exposed to non-human tissue.
The kit is used to size a patient's mitral or tricuspid valve in cardiac procedures. Look for the GTIN: 00643169707535 on the product packaging.
Look for the GTIN: 00643169707535 on the product packaging to identify the recalled kit.
The demonstration kits might have been contaminated with porcine tissue during use in wet labs.
The recall indicates potential cross-contamination risk, so it is not recommended for patient use without verification.
Check the product packaging for the GTIN: 00643169707535.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1449-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1449-2020 from Medtronic. 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.
