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U.S. Department of Health and Human Services

Class 1 Device Recall iCross Coronary Imaging Catheter

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  Class 1 Device Recall iCross Coronary Imaging Catheter see related information
Date Initiated by Firm March 28, 2011
Date Posted June 10, 2011
Recall Status1 Terminated 3 on July 30, 2012
Recall Number Z-2419-2011
Recall Event ID 58405
510(K)Number K050577  K063312  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Boston Scientific, Atlantis ¿ SR Pro 2, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, USE BY 2011-05, REF 39014, UPN H749390140, Sterile R Sterilized using irradiation, Made in USA 47900 Bayside Parkway, Fremont, CA 94538
The intended use as stated in Japan Shonin 21200BZY00484000: This product is an imaging catheter with built-in ultrasonic transducer that sends ultrasound waves inside the blood vessel to perform B-mode ultrasonagraphy. The indications for use as stated in the 510(k) and DFU 90606867: The Atlantis coronary catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular Ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Code Information All lots are impacted
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Brent Hathcock
763-494-7971
Manufacturer Reason
for Recall		 Catheter tip detachment that is not associated with elongation of the catheter typically caused by excessive pulling forces. EXPANDED: Boston Scientific is initiating a recall of all iCross Coronary Imaging Catheters because they have received and confirmed 8 occurrences of catheter tip detachments due to embrittlement.
FDA Determined
Cause 2		 Process design
Action Boston Scientific " Important Customer Notification" letters dated March 14, 2011 were hand delivered to customers by Boston Scientific sales representatives starting on March 28th, 2011. The sales representatives verbally reviewed information. A tracking log will be maintained document completion of the customer notifications. The letter described the product, problem and possible root cause as well as one corrective action, a change in sterilization method from Gamma to E-beam implementation. Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter dated May 26, 2011, to all affected customers. Customers were instructed to Identify and discontinue use of any affected product within their inventory and to segregate it immediately and return it to Boston Scientific
Quantity in Commerce 30,669
Distribution Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Japan, Trinidad, Tobago, and American Virgin Islands.
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 = DQO and Original Applicant = BOSTON SCIENTIFIC CORP.
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