FDA Device recall Z-1449-2020
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac proce…
- FDA Device
- Class II
- ongoing
- Published 2020-03-18
On 2020-03-18 the FDA classified a Class II recall of Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac proce… by Medtronic Corevalve, citing 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 conta….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1449-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-01-14 |
| Published | 2020-03-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Corevalve |
| Distribution | US |
Product
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
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.
Identifiers
| code_info | GTIN: 00643169707535 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1449-2020%22
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