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U.S. Department of Health and Human Services

Class 3 Device Recall Cilli II Catheter

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  Class 3 Device Recall Cilli II Catheter see related information
Date Initiated by Firm December 30, 2005
Date Posted February 04, 2006
Recall Status1 Terminated 3 on August 24, 2006
Recall Number Z-0473-06
Recall Event ID 34322
PMA Number P980003 
Product Classification unknown device name - Product Code LPD
Product Chilli II Cooled Ablation Cathether, Model M00490310
Code Information Batch Numbers: 804828 and 8048029
Recalling Firm/
Manufacturer		 Boston Scientific Corp
2710 Orchard Pkwy
San Jose CA 95134
For Additional Information Contact Deborah Springer
408-895-3626
Manufacturer Reason
for Recall		 Product is mislabeled with the incorrect catheter curve description.
FDA Determined
Cause 2		 Other
Action On 12/30/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
Quantity in Commerce 35 units
Distribution Product was released for distribution to 14 consignees in US.
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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