Medtronic Simulus 750 Flexible Ring/Band Accessory Kit recall
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Why was Medtronic Simulus 750 Flexible Ring/Band Accessory Kit 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 00643169707535
- Product
- Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
- Recalling firm
- Medtronic CoreValve LLC
- Quantity
- 6
- Distribution
- US Nationwide distribution in the states of Ohio and Kansas.
- Recall date
- March 18, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)