Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size… — Class II medical device recall Z-1450-2020
Ongoing recall by Medtronic CoreValve LLC, reported 2020-03-18, distributed nationwide. Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstra
| Recall number | Z-1450-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic CoreValve LLC, Santa Ana, CA, United States |
| Recall initiated | 2020-01-14 |
| Classified | 2020-03-06 |
| Reported by FDA | 2020-03-18 |
| Distributed | Nationwide (US) |
| Quantity | 6 |
| UPC / GTIN / UDI-DI | 00643169707573 |
Product
Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1450-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.