Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid val

FDA device recall Z-1449-2020 · posted 2020-02-14 · Open, Classified

Recall details

Recalling firm

Medtronic CoreValve LLC

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.

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

DTI

Quantity affected

6

Distribution

US Nationwide distribution in the states of Ohio and Kansas.

Date initiated

2020-01-14

Date posted

2020-02-14

Location

Santa Ana, CA