Boston Scientific Mach 1 Guide Catheter Femoral Approach, 8F, 0.091'', Amplatz Right Curve, UPN # H74934358180, Catalog # 34358-18. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.
FDA Recall Z-0385-2007 · Posted 2007-02-07
Recalling FirmBoston Scientific
Recall StatusTerminated
Product CodeDQY
Date Initiated2006-12-13
Date Terminated2007-06-28
Product Quantity4
Reason for Recall
Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an embolization resulting from the excess resin detaching from the device during the procedure.
Firm Action
An Urgent Medical Device Recall letter, dated 12/13/06, and a Clarification of Recall Notification letter, dated 12/14/06, were sent to all affected hospitals. The letter describes the issue, affected product, asks for customers to discontinue further distribution or use of any remaining product and asks for product to be returned. Replacement product will be available for any/all returned product.
Root Cause
Other
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.