Class 2 Device Recall Atlantis PV 15 MHz Peripheral Imaging Catheter

• Date Initiated by Firm: January 06, 2014
• Date Posted: January 30, 2014
• Recall Status: Terminated 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/ Manufacturer: Boston Scientific Corporation; 47215 Lakeview Blvd; Fremont CA 94538-6530
• For Additional Information Contact: Brent Hathcock; 463-494-1133
• 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: 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