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U.S. Department of Health and Human Services

Class 3 Device Recall Guiding Catheter

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 Class 3 Device Recall Guiding Cathetersee related information
Date Initiated by FirmDecember 07, 2004
Date PostedJanuary 26, 2005
Recall Status1 Terminated 3 on November 19, 2008
Recall NumberZ-0434-05
Recall Event ID 30637
510(K)NumberK021593 
Product Classification Catheter, Percutaneous - Product Code DQY
ProductVISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.
Code Information Product Code 67021055, lot X0704002
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 NW 60th Ave
Miami Lakes FL 33014-2802
Manufacturer Reason
for Recall		Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an 'RDC' shape rather than the 'RDC(1)' shape. The RDC shape has a larger curve. The product was manufactured with the incorrect forming wire during the guiding catheter manufacturing process.
FDA Determined
Cause 2		Other
ActionPackets containing the Customer Letter and Acknowledgement Form for each domestic consignee were sent by overnight delivery to the appropriate Cordis Endovascular sales representatives. The letter is being hand-delivered to each initial domestic consignee by the Cordis Endovascular sales representative. Any remaining units at the account will be removed from the shelf and returned to Cordis. The account will be asked to sign the Acknowledgement Form.
Quantity in Commerce153 units
DistributionDistributed to 57 accounts throughout the United States and three international accounts.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQY
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