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U.S. Department of Health and Human Services

Class 2 Device Recall Stretta

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  Class 2 Device Recall Stretta see related information
Date Initiated by Firm February 21, 2003
Date Posted March 20, 2003
Recall Status1 Terminated 3 on April 21, 2003
Recall Number Z-0663-03
Recall Event ID 25680
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
Product Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K
Code Information FD1268 thru FD1282
Recalling Firm/
Manufacturer		 Curon Medical Inc
735 Palomar Avenue
Sunnyvale CA 94086
For Additional Information Contact Vivian Filimon
408-616-1841
Manufacturer Reason
for Recall		 Catheter shaft has potential to crack during use.
FDA Determined
Cause 2		 Other
Action On 2/21/03 the firm initiated the recall and its notification was via letters to inform its consignees about the problem with its catheters. It requests immediate discontinuance of all product with certain lot numbers.
Distribution Product was released for distribution to 52 direct accounts nationwide including 1 VA Medical Center, Endoscopy Dept., 150 S. Huntington Ave., Boston, MA 02130, ATTN: Dr. Hiroshi Mashimo, ph#: 617-363-5640.
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.
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