Z-1450-2020Class II

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

Name: Z-1450-2020 Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve...
Creator: Medtronic CoreValve LLC
Published: 2020-01-14
License: https://open.fda.gov/license/

Medtronic Heart Valves Division / initiated 2020-01-14 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic CoreValve LLC began a recall of Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures on 2020-01-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1450-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-01-14
Posted: 2020-02-14
Recalling firm: Medtronic Heart Valves Division
Product: Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Product code: DTI Sizer, Heart-Valve, Prosthesis
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 6
Distribution: US Nationwide distribution in the states of Ohio and Kansas.
Product codes and lots: GTIN: 00643169707573

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1450-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1449-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-03-18	2020-03-06
Z-1450-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-03-18	2020-03-06

Product code DTI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)