Boston Scientific Corp Vaxcel Implantable Vascular Access System -Titanium Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-315, UPN/Material No. M001453150, Single Use Only, STERILE, EO. Boston Scientific MEDI-TECH, (617) 972-4000/(800) 225-3238, 480 Pleasant Street, Watertown, MA 02472 --- The port is provided as a kit, with various single use, disposable items necessary for achieving vascular access and implanting the port catheter. Each kit is provided in a plastic (PETG) tray with a heat-sealed tyv Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Vaxcel Implantable Vascular Access System -Titanium Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-315, UPN/Material No. M001453150, Single Use Only, STERILE, EO. Boston Scientific MEDI-TECH, (617) 972-4000/(800) 225-3238, 480 Pleasant Street, Watertown, MA 02472 --- The port is provided as a kit, with various single use, disposable items necessary for achieving vascular access and implanting the port catheter. Each kit is provided in a plastic (PETG) tray with a heat-sealed tyv
Brand
Boston Scientific Corp
Lot Codes / Batch Numbers
Lots 1103350 and 1113798
Products Sold
Lots 1103350 and 1113798
Boston Scientific Corp is recalling Vaxcel Implantable Vascular Access System -Titanium Standard Port With 9F Polyurethane Catheter, Cat due to Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by supplier B. Brau. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by supplier B. Braun Medical of the error)
Recommended Action
Per FDA guidance
Boston Scientific sent Urgent Medical Device Recall Notification- Immediate Action Required letters- (dated 6/13/06) to all 11 end users via Federal Express. The letters informed the end users that some of the peelable sheaths/dilators in the Vaxcel Implantable Vascular Access kits may incorrectly contain 10F sheaths instead of 9F sheaths which had been supplied by B. Braun Medical Inc. Improper sizing of the sheath for the catheter may result in difficulty /inability to insert the catheters. The letters instructed the end users to immediately remove the affected lots from inventory, segregate the recalled product, contact Boston Scientific at 1-800-862-1284 to obtain a Return Authorization (RGA) number, pack the product in an appropriate shipping carton, affix the shipping label to the outside of the shipping carton, write the RGA number on the outside of the shipping carton, and to return the recalled product to Boston Scientific''s Distribution Center Attn: QA Returns, 500 Commander Shea Blvd., Quincy, MA 02171. Accompanying each letter was a Reply Verification Tracking Form to be completed by the end user and mailed or faxed to Boston Scientific even if the user did not have the recalled lots on hand.
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
CA, MD, NY, TN, WA
Page updated: Jan 10, 2026