Recall Z-1450-2020
Medtronic CoreValve LLC · initiated January 14, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Codes / lots: GTIN: 00643169707573
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.
FDA-determined 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.
Details
- Recall number
- Z-1450-2020
- Initiated
- January 14, 2020
- Posted by FDA
- February 14, 2020
- Product code
- DTI – Sizer, Heart-Valve, Prosthesis
- Quantity
- 6
- Distribution
- US Nationwide distribution in the states of Ohio and Kansas.
- Recalling firm
- Medtronic CoreValve LLC, Santa Ana, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1449-2020 Class II | Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a…Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The… | 01/14/2020Open, Classified |