Boston Scientific Corporation One Boston Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in (internal dia), shaft lenght, 90 cm, Catalon Number: 34356-446, UPN H749343564460, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in (internal dia), shaft lenght, 90 cm, Catalon Number: 34356-446, UPN H749343564460, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311
Brand
Boston Scientific Corporation One Boston
Lot Codes / Batch Numbers
Lot Number: 20022689
Products Sold
Lot Number: 20022689
Boston Scientific Corporation One Boston is recalling Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in (internal dia), shaft due to Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
Recommended Action
Per FDA guidance
Consignees were sent a Boston Scientific Urgent Voluntary Medical Device Recall letter on 2/7/08. The letter included the customer steps for recall, a complete listing of all product batches being recalled, the Reply Verification Tracking Form(s) and a return shipping label.
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 noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, DE, FL, IL, IN, KY, MI, MN, NJ, NY, NC, ND, OH, OR, PA, TN, TX, WA, WV, WI
Page updated: Jan 10, 2026