Recall Z-1450-2020 ยท DTI Sizer, Heart-Valve, Prosthesis
Medtronic CoreValve LLC
Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
| Date | Feb 14, 2020 (initiated Jan 14, 2020) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 6 |
| Distribution | US Nationwide distribution in the states of Ohio and Kansas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.