Events

Recall of Device Recall Boston Scientific, IMAGER II Urology Torque Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61505
  • Event Risk Class
    Class 2
  • Event Number
    Z-1393-2012
  • Event Initiated Date
    2012-03-15
  • Event Date Posted
    2012-04-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108294
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, urological - Product Code KOD
  • Reason
    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.
  • 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.

Device

Device Recall Boston Scientific, IMAGER II Urology Torque Catheter
  • Model / Serial
    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.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product Description
    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.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA