Date Initiated by Firm | January 14, 2020 |
Date Posted | February 14, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1449-2020 |
Recall Event ID |
84837 |
Product Classification |
Sizer, heart-valve, prosthesis - Product Code DTI
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Product | Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures. |
Code Information |
GTIN: 00643169707535 |
Recalling Firm/ Manufacturer |
Medtronic CoreValve LLC 1851 E Deere Ave Santa Ana CA 92705-5720
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For Additional Information Contact | Rick Leonard 763-514-9609 |
Manufacturer 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 2 | 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 in Commerce | 6 |
Distribution | US Nationwide distribution in the states of Ohio and Kansas. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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