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U.S. Department of Health and Human Services

Medical Device Recalls

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  Medical Device Recalls see related information
Date Initiated by Firm March 25, 2008
Create Date August 27, 2008
Recall Status1 Terminated 3
Recall Number Z-1775-2008
Recall Event ID 47795
Product Hall Easy-Fit? Prosthetic Heart Valve - Mitral M7700. The device uses a single pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is machined into final configuration from a single piece of solid titanium and has no welds or introduced bends. It is an open-membered design in which all members project centrally without distal attachment. A rotatable fabric sewing ring is affixed to the valve. The valve is provided on a holder (collect) to facilitate insertion and to provide protection during shipping and handling. The valve is sterile and non-pyrogenic if seal and package are not opened, damaged, or broken.
Recalling Firm/
Manufacturer
Medtronic Heart Valve Division
8299 Central Ave Ne
Spring Lake Park MN 55432-2023
For Additional Information Contact
763-514-6600
Manufacturer 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 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.
Quantity in Commerce 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, Germany, India, Italy, Netherlands, Poland, Romania, Russian Federation, South Africa, and Turkey.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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