Reported Mar 18, 2020 · Ongoing
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid…
Medtronic CoreValve LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic CoreValve LLC · 1851 E Deere Ave · Santa Ana, CA · 92705-5720
Is this the product you have?
- Medtronic Simulus 750 Flexible
- Ring/Band Accessory Kit - Product UsageUsed to size a patient's mitral or tricuspid valve in cardiac procedures
- Lot codes and dates
- GTIN00643169707535
- Amount recalled
- 6
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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