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U.S. Department of Health and Human Services

Class 2 Device Recall Atlantis PV 15 MHz Peripheral Imaging Catheter

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  Class 2 Device Recall Atlantis PV 15 MHz Peripheral Imaging Catheter see related information
Date Initiated by Firm January 06, 2014
Date Posted January 30, 2014
Recall Status1 Terminated 3 on October 29, 2014
Recall Number Z-0900-2014
Recall Event ID 67298
510(K)Number K080272  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter:
Sterile, R; Sterilized using irradiation.

Product Usage:
This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire.
Code Information Product number: H749364560, Catalog number: 36456; Lot numbers:  16159358, 16183964, 16230195, 16230673, 16247263, 16257809, 16268498, 16289177, 16311356, 16330543, 16342824, 16419885, 16420624, 16420903, 16447744, 16458536, 16486133, 16494530; Expiration Date: June 11th 2014 to October 29th 2014. 
Recalling Firm/
Boston Scientific Corporation
47215 Lakeview Blvd
Fremont CA 94538-6530
For Additional Information Contact Brent Hathcock
Manufacturer Reason
for Recall
Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter.
FDA Determined
Cause 2
Equipment maintenance
Action Boston Scientific sent an Urgent Medical Device Recall Removal letter dated January 14, 2014 to all affected customers by overnight mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete an Account Reply verification Tracking Form in order to received a Return Goods Authorization number for product return. For questions contact your local Sales Representative.
Quantity in Commerce 1068 single units
Distribution US Nationwide Distribution and Mexico
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.