FDA recall Z-1533-2020

Product

Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm

Reason for recall

Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral.

Distribution

China

Key facts

Status

Terminated

Initiation date

2020-02-11

Report date

2020-04-01

Termination date

2022-03-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1533-2020