Simulus recallZ-1450-2020 · Medtronic CoreValve LLC · initiated Jan 14, 2020
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic CoreValve LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1450-2020
- Status
- Open, Classified
- Initiated by the company
- Jan 14, 2020
- Posted by the FDA
- Feb 14, 2020
- Recalling firm
- Medtronic CoreValve LLC
- Quantity
- 6
- Product code
- DTI
- Distribution
- US Nationwide distribution in the states of Ohio and Kansas.
Product description
Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Code information (models, lots, serial numbers)
GTIN: 00643169707573
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Simulus™ 850Medtronic, Inc. · SIZER, HEART-VALVE, PROSTHESIS1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 84837).
- Z-1449-2020 · Open, ClassifiedMedtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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