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Open, Classified

Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.

FDA Recall Z-1450-2020 · Posted 2020-02-14

Recalling FirmMedtronic CoreValve LLC
Recall StatusOpen, Classified
Product CodeDTI
Date Initiated2020-01-14
Product Quantity6

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution in the states of Ohio and Kansas.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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