Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
- Company
- Medtronic Corevalve Llc
- Recall Initiated
- January 14, 2020
- Posted
- February 14, 2020
- Recall Number
- Z-1449-2020
- Quantity
- 6
- Firm Location
- Santa Ana, CA
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of Ohio and Kansas.
Lot / Code Info
GTIN: 00643169707535
Root Cause
Nonconforming Material/Component
Action Taken
The firm initiated the recall by email or verbal contact on 01/14/2020. The direct consignees (sales representatives) were directed to quarantine and return the affected product. On 02/05/2020, consignees (hospitals) were notified by letter delivered by the Medtronic Sales Representatives. The notices directed the consignee to not use the affected product for clinical use, quarantine and return affected product. Affected product will be replaced by Medtronic.