FDA Medical Device Recalls (openFDA)
Medtronic CoreValve LLC: Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
- Recall number
- Z-1450-2020
- Recalling firm
- Medtronic CoreValve LLC
- Product
- Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
- Status
- Open, Classified
- Initiated
- 2020-01-14
- Posted
- 2020-02-14
- Terminated
- not on file
- Reason
- 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.
- Root cause
- 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
- 6
- Distribution
- US Nationwide distribution in the states of Ohio and Kansas.
- Lot, serial or model codes
- GTIN: 00643169707573
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DTI
- Firm FEI
- 2025587
- Firm city
- Santa Ana
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28