Boston Scientific Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Internal Mammary Curve, UPN # H74934356260, Catalog # 34356-26. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Internal Mammary Curve, UPN # H74934356260, Catalog # 34356-26. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.
Brand
Boston Scientific
Lot Codes / Batch Numbers
Batch / Lot # 687532
Products Sold
Batch / Lot # 687532
Boston Scientific is recalling Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Internal Mammary Curve, UPN # due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026