—#42598

Product

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 product code: LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K954258
Affected lot / code info: 1007398, 1017115, 1018449

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Boston Scientific Pl, Natick, Massachusetts 01760-1536

Distribution

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

Timeline

Recall initiated: 2005-10-28
Posted by FDA: 2006-01-06
Terminated: 2007-02-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #42598. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.