—#37535

Product

Vaxcel Low Profile Port with PASV valve and 8F Polyurethane Catheter. CATALOG NO. 45-238, Ref. # M001452380. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

FDA product code: LLD — Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K031844
Affected lot / code info: Cat. No. 45-238 including all lots as follows: 791484, 791485, 906777, 916195, 916196, 916197, 917026, 918870, 919481, 920550, 921765, 924851D

Why it was recalled

Potential separation of the port base from the port cover after implantation.

Root cause (FDA determination)

Other

Action the firm took

Letters sent 3/11/2005 via Federal Express to hospitals receiving affected product. Customers instructed to remove/return product, notify physicians, evaluate patients and explant devices whenever possible.

Recalling firm

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

Distribution

Distribution pattern: 1215 units shipped to 123 hospitals throughout the U.S. 2 units shipped to Boston Scientific in South Africa where 1 unit had been used as a demo (non-human use) and 1 units is in BSC control

Timeline

Recall initiated: 2005-02-25
Posted by FDA: 2005-04-28
Terminated: 2006-08-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #37535. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.