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U.S. Department of Health and Human Services

Class 2 Device Recall Atlantis PV Peripheral Imaging Catheter,

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  Class 2 Device Recall Atlantis PV Peripheral Imaging Catheter, see related information
Date Initiated by Firm October 09, 2008
Date Posted January 28, 2009
Recall Status1 Terminated 3 on July 27, 2009
Recall Number Z-0837-2009
Recall Event ID 50140
510(K)Number K080272  
Product Classification transducer, ultrasonic, diagnostic - Product Code ITX
Product Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA.
Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Code Information Batch/lot #s 11420600, 11420601, 11420602, 11611665, 11716746, 11720663, 11721240, 11722752, 11727107, 11727873, 11727874, 11728458, 11731354, 11732665, 11735762, 11736559, 11739563, 11742590, 11754455, 11758051, 11764281, 11777994, 11788045, 11790848, 11820112, 11897802, 11897904, and 11904295
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact
508-652-5594
Manufacturer Reason
for Recall		 Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year.
FDA Determined
Cause 2		 Labeling mix-ups
Action Recall initiated on October 6, 2008, and notification letters sent on October 8, 2008. Letters were sent via FedEx. Responses are being tracked along with delivery verification. For additional information contact Boston Scientific Corporation at 1-508-652-5594.
Quantity in Commerce 1033 units
Distribution Worldwide Distribution --- USA including Puerto Rico and country of Panama
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 = ITX and Original Applicant = BOSTON SCIENTIFIC CORP.
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