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.
FDA Recall Z-1775-2008 · Posted 2008-08-27
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Recalling FirmMedtronic Heart Valve Division
Recall StatusTerminated
Date Initiated2008-03-25
Date Terminated2012-05-15
Product Quantity30 (USA), 187 (EUROPE), 3 (CANADA), 95 (HONG KONG AND AUSTRALIA)
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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