Hall Easy-Fit Prosthetic Heart Valve - Mitral M7700. The device uses a single pyrolytic carbon disc occluder pivoting wi

FDA device recall Z-1775-2008 · posted 2008-08-27 · Terminated

Recall details

Recalling firm

Medtronic Heart Valve Division

Reason for recall

Medtronic has identified an issue with 685 Hall Easy-Fit valves Models A7700 and M7700 in which the holder of the valve was incorrectly secured to the valve. This could potentially make it difficult to easily disengage the holder from the valve.

Action taken

A Medtronic "Urgent Communication" letter dated March 24, 2008 was sent to consignees on 3/25/08. The letter describes the product and problem. The letter requests that they return the impacted devices and to return the reconciliation form "Medtronic Recall Certificate (FCA0807)" confirming whether they have the valves in inventory or if they have been implanted.

Root cause

Process control

Status

Terminated

Quantity affected

30 (USA), 187 (EUROPE), 3 (CANADA), 95 (HONG KONG AND AUSTRALIA)

Distribution

Class II Recall - Worldwide Distribution --- including USA states of TX, WY, CA, MI, WI, MO, IL, NY, TN, AR, LA, KY, WA, WV, and countries of Canada, Hong Kong, Australia, Albania, Belgium, Croatia, G

Date initiated

2008-03-25

Date posted

2008-08-27

Date terminated

2012-05-15

Location

Spring Lake Park, MN