Class 1 Device Recall Atlantis(r) SR Pro 2, 40 MHz Coronary Imaging Catheter

• Date Initiated by Firm: March 28, 2011
• Date Posted: June 10, 2011
• Recall Status: Terminated on July 30, 2012
• Recall Number: Z-2418-2011
• Recall Event ID: 58405
• 510(K)Number: K050577 K063312
• Product Classification: Catheter, intravascular, diagnostic - Product Code DQO
• Product: Boston Scientific iCross, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, REF / Catalog No. 51805, UPN / Product No. H749518050, Sterilized using irradiation, Made in USA 47900 Bayside Parkway, Fremont, CA 94538 This catheter is 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. 13478001, 13479862, 13483687, 13483794, 13486679, 13488281, 13492691, 13495381, 13495537, 13501702, 13509959, 13510363, 13510388, 13510970, 13513269, 13513370, 13518405, 13522499, 13525880, 13526246, 13529890, 13532559, 13532599, 13534080, 13537206, 13537450, 13541221, 13542989, 13543371, 13543372, 13543373, 13543374, 13543903, 13544086, 13548035, 13550071, 13551639, 13555107, 13557249, 13558528, 13560226, 13561192, 13561925, 13565449, 13572049, 13575534, 13576371, 13582549, 13587068, 13589401, 13591521, 13595076, 13598770, 13602027, 13604910, 13605911, 13607907, 13612369, 13613621, 13616694, 13617441, 13620814, 13623271, 13625428, 13627096, 13627610, 13628377, 13628378, 13628480, 13642454, 13644574, 13645440, 13648480, 13649064, 13649555, 13651806, 13659069, 13660352, 13663881, 13666991, 13670858, 13671958, 13675335, 13677173, 13679538, 13681808, 13685028, 13692281, 13711461, 13717161, 13721872, 13726417, 13729970, 13733692, 13736433, 13738543, 13744275, 13748118, 13751320, 13753544, 13755722, 13763259, 13766230, 13770525, 13772349, 13774311, 13779785, 13790510, 13795482, 13796520, 13799042, 13803863, 13807009, 13807405, 13810319, 13811040, 13813370, 13817138, 13823987, 13827155, 13828363, 13830503, 13834945, 13837411, 13846140, 13862022, 13866829, 13867763, 13867812, 13869465, 13871530, 13874961, 13874989, 13878848, 13881217, 13881902, 13883719, 13886293, 13889336, 13889690, 13892663, 13893369, 13897082, 13900781, 13906150, 13908756, 13909098, 13909550, 13909967, 13912695, 13913663, 13915857, 13916951, 13916953, 13920105, 13920710, 13920803, 13920805, 13921106, 13923537, 13924672, 13927066, 13928293, 13930289, 13932251, 13932695, 13935416, 13935514, 13936063, 13938497, 13938680, 13940859, 13943943, 13947364, 13950149, 13960559, 13964584, 13967316, 13970980, 13977845, 13982090, 13987794, 13990244, 13994171, 13997365, 14001705, 14006979, 14023919, 14032268, 14036676, 14038052, 14043294, 14048150, 14052253, 14054270, 14057246, 14059185, 14060218, 14060730, 14063990, 14064764, 14068345, 14071841, 14075967, 14075968, 14080311, 14081712, 14083655, 14086847, 14090453, 14090833, 14094058, 14098066, 14099289, 14101324, 14102725, 14105453, 14106322, 14109716, 14109807, 14113183, 14117941, 14125549, 14137883, 14140518, 14144461, 14147692, 14154145, 14156848, 14162309, 14164380, 14165091, 14167666, 14179509, 14183540, 14186298, 14191171, 14194753, 14198644, 14202609, 14203395, 14206342, 14206443, 14209358, 14210282, 14217182, 14219362, 14219394, 14226258, 14230360, 14235075, 14238057, 14239219, 14253978, 14255111, 14256086, 14256852, 14257870, 14258124, 14258292, 14260466, 14262256, 14267351, 14272686, 14272726, 14274123, 14275822, 14276666, 14278698, 14279887, 14280587, 14283635, 14285242, 14287832, 14289523.
• 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: 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: 66,033
• 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