Medtronic recalls Simulus 850 Semi-Rigid Ring/Band Accessory Kits due to potential porcine tissue contamination in demonstration kits. This affects cardiac procedure kits used for valve sizing.
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 Simulus 850 Semi-Rigid Ring/Band Accessory Kits used in cardiac procedures because demonstration kits might have been contaminated with non-human tissue. This could pose a risk if the kit is used in human procedures.
The demonstration kits, designed for use in wet labs, may have come into contact with porcine (pig) tissue. If these kits are used in human cardiac procedures, there is a potential risk of cross-contamination.
Healthcare professionals using the Simulus 850 kits for cardiac valve sizing are most at risk. Patients receiving these kits during procedures could be affected if contamination occurs.
Check for the Simulus 850 Semi-Rigid Ring/Band Accessory Kit with GTIN 00643169707573. These kits were used for sizing mitral or tricuspid valves in cardiac procedures.
Look for the GTIN 00643169707573 on the Simulus 850 Semi-Rigid Ring/Band Accessory Kit.
The demonstration kits could have come into contact with non-human (porcine) tissue, posing a potential cross-contamination risk if used in human procedures.
The recall is for demonstration kits that might have been contaminated; actual patient use is not directly affected unless the contaminated kit is used in procedures.
Check for the GTIN 00643169707573 on the Simulus 850 Semi-Rigid Ring/Band Accessory Kit used for cardiac valve sizing.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1450-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1450-2020 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.
