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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 29, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on October 13, 2005
Recall Number Z-0847-04
Recall Event ID 28675
510(K)Number K991897  
Product Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/REF: PRTB10A, Model No. M001PRTB10A. Firm on label: Boston Scientific Corp., NAMIC Technology Center, Glens Falls, NY 12801.
Code Information 916252, 917973
Recalling Firm/
Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Nancy Cutino
Manufacturer Reason
for Recall
Catheters may not have adequate radiopacity for proper visualization under fluoroscopy.
FDA Determined
Cause 2
Action Letters dated 3/29/04 with instruction to remove and return product.
Quantity in Commerce 72 units

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 = and Original Applicant = CATHETER INNOVATIONS, INC.