Class 2 Device Recall Boston Scientific, IMAGER II Urology Torque Catheter

• Date Initiated by Firm: March 15, 2012
• Date Posted: April 11, 2012
• Recall Status: Terminated on April 14, 2014
• Recall Number: Z-1393-2012
• Recall Event ID: 61505
• 510(K)Number: K011965 K102527
• Product Classification: Catheter, urological - Product Code KOD
• Product: Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. The following products being recalled: Imager" II Catheters C1 5fr 65cm M0064003001 M0064003000 400-300 Imager" II Catheters C2 5fr 65cm M0064003011 M0064003010 Catalog # 400-301 Imager" II Catheters Straight 5fr 65cm M0064003021 M0064003020 Catalog #400-302 Imager" II Catheters Bern 5fr 65cm M0064003031 M0064003030 Catalog #400-303 Imager" II Catheters JB1 5fr 65cm M0064003041 M0064003040 Catalog #400-304 Imager" II Catheters Straight 5fr 100cm M0064004021 M0064004020 Catalog #400-402 Imager" II Catheters Bern 5fr 100cm M0064004031 M0064004030 Catalog #400-403 Imager" II Catheters JB1 5fr 100cm M0064004041 M0064004040 Catalog #400-404 Imager" II Catheters Bern 5fr 40cm M0064005031 M0064005030 Catalog #400-503 The Imager II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material. The Imager II Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop", intended for use in the urinary tract.
• Code Information: Imager" II Catheters C1 5fr 65cm M0064003001 M0064003000 Catalogue #400-300 Lot/Batch Number: 00064016, 00065473, 00066117, 00067636, 00068586, 00069553, 00070089, 00070791, 00071534, 00072320,00073679, 00073780, 00076129. Imager" II Catheters C2 5fr 65cm M0064003011 M0064003010 Catalogue #400-301 Lot/Batch Number:00063007, 00064018, 00065474, 00066588, 00067128, 00068068, 00073781, 00074282, 00075160, 00075362,00076130. Imager" II Catheters Straight 5fr 65cm M0064003021 M0064003020 Catalogue #400-302 Lot/Batch Number:00063008, 00064020, 00065475, 00066590, 00067130,00068069, 00069554, 00071536, 00071619, 00073784, 00074284, 00074829, 00075159. Imager" II Catheters Bern 5fr 65cm M0064003031 M00640030300 Catalogue #400-303 Lot/Batch Number:0064022, 00064918, 00065472, 00066119, 00066586,00067635, 00068584, 00068896, 00069555, 00069965, 00070090, 00070789, 00071532, 00071617, 00072318, 00073681, 00073778, 00074281, 00074828, 00076127. Imager" II Catheters JB1 5fr 65cm M0064003041 M0064003040 Catalogue #400-304 Lot/Batch Number:00064030, 00068587, 00069556, 00071535, 00071618,00073782, 00076131. Imager" II Catheters Straight 5fr 100cm M0064004021 M0064004020 Catalogue #400-402 Lot/Batch Number: 00066123, 00066589, 00068993, 00069557, 00070792,00072321, 00073783, 00074283, 00075363. Imager" II Catheters Bern 5fr 100cm M0064004031 M0064004030 Catalogue #400-403 Lot/Batch Number:00063006, 00064034, 00065926, 00070094, 00070788,00071616, 00073680, 00074827, 00076126. Imager" II Catheters JB1 5fr 100cm M0064004041 M0064004040 Catalogue #400-404 Lot/Batch Number: 00067129. Imager" II Catheters Bern 5fr 40cm M0064005031 M0064005030 Catalogue #400-503 Lot/Batch Number: 00064919, 00066121, 00066587, 00068585, 00068992,00070092, 00070790, 00071533, 00072319, 00073779, 00075161, 00076128.
• FEI Number: 3002095335
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Scimed Pl; Maple Grove MN 55311-1565
• For Additional Information Contact: 763-494-1700
• Manufacturer Reason for Recall: Boston Scientific Corporation is initiating a Medical Device Recall of certain lots/batches of the Imager" II Catheter (Urology) and the Imager" II Angiographic Catheter . An investigation has found that, during shipping, some units in the 5-pack box may experience a physical interaction between the carton and the area on the pouch where the hub is located. This interaction was found to cause pi
• FDA Determined Cause: Package design/selection
• Action: Boston Scientific sent an " Urgent Medical Device Recall" letter dated March 14. 2012. the letter was addressed to "Dear Risk/Materials Manager. The letter described the problem and the product involved in the recall. Advised consignees to cease the distribution of any remaining unused product affected. Advised distributors that the recall notification should be forwarded to their customers. Requested consignees to complete and return the Reply Verification tracking Form enclosed by fax to 508-683-5578. For questions regarding this recall 763-494-1700. Recall Expanded 4/24/12: Imager II Angiographic customers: Eight total number of customers not notified initially (3 USA and 5 APA customers were sent the same initial letter with a a revised send date of April 18, 2012, 329 total number of US Customers notified initially with an incomplete product list were sent a revised notification letter. Urology: Imager II Torque customers: 1 US Customer was not notified initially. This customer was sent the same initial letter with a revised send date of April 18, 2012. Fifteen US Customers notified with incomplete product list. These customers were sent a revised notification letter.
• Quantity in Commerce: 11,340 (8,485 USA, 2,845 OUS)
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Arab Emir, Azerbaijan, Austria, Australia, Azerbaijan, Belgium, Bulgaria, Bahrain, Bermuda, Brazil, White Russia, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Denmark, Ecuador, Estonia, Egypt, Spain, Finland, France, Great Britain, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Ireland, Israel, Italy, Jordan, South Korea, Kuwait, Lebanon, Lithuania, Morocco, Malta, Mexico, Malaysia, Netherlands, Norway, New Zealand, Oman, Panama, Peru, Pakistan, Poland, Portugal, Qatar, Romania, Serbia, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, El Salvador, Syria, Thailand, Tunisia, Turkey, Trinidad, Tobago, Taiwan, Ukraine, Vietnam, South Africa, Dutch Antilles, Sri Lanka, Libya, and Yemen
• 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 = KOD; 510(K)s with Product Code = KOD