Express 2 Monorail Coronary Stent Systems (bare metal stents) - balloon expandable Express 316L stainless steel Stent premounted on a MONORAIL catheter with a Dynaleap balloon.
FDA Recall Z-1121-04 · Posted 2004-07-27
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeMAF
Date Initiated2004-07-16
Date Terminated2005-11-29
Product Quantity82,424
Reason for Recall
Due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure.
Firm Action
Press release has been issued. Institutions with affected units will receive packages outlining the recall process and should immediately discontinue use of these units. Clinician and patient inquiries may be directed to Boston Scientific.
Root Cause
Other
Distribution Pattern
Inside U.S.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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