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Terminated

Vaxcel Implantable Vascular Access System - Titanium Mini Port with 7F Polyurethane Catheter. Boston Scientific Catalog # 45-305, M001453050. Firm on label: Boston Scientific/Medi-Tech, Watertown, MA 02472

FDA Recall Z-0340-06 · Posted 2006-01-06

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLJS
Date Initiated2005-10-28
Date Terminated2007-02-15
Product Quantity300 units

Reason for Recall

Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.

Firm Action

Boston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product.

Root Cause

Other

Distribution Pattern

DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K954258TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)Gerard Medical Enterprises, Inc. · 1996-05-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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