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U.S. Department of Health and Human Services

Class 2 Device Recall Vaxcel Port with PASV Valve

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  Class 2 Device Recall Vaxcel Port with PASV Valve see related information
Date Initiated by Firm February 25, 2005
Date Posted April 28, 2005
Recall Status1 Terminated 3 on August 09, 2006
Recall Number Z-0782-05
Recall Event ID 31251
510(K)Number K031844  
Product Classification Port & Catheter, Implanted, Subcutaneous, Intraperitoneal - Product Code LLD
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.
Code Information Cat. No. 45-238 including all lots as follows: 791484, 791485, 906777, 916195, 916196, 916197, 917026, 918870, 919481, 920550, 921765, 924851D
Recalling Firm/
Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Marie Peters
Manufacturer Reason
for Recall
Potential separation of the port base from the port cover after implantation.
FDA Determined
Cause 2
Action 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.
Quantity in Commerce 841 units
Distribution 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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLD and Original Applicant = BOSTON SCIENTIFIC CORP.