Events

Recall of Device Recall Convoy Soft Tip Sheath Multipurpose Introducing Sheath Kits

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

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
    50771
  • Event Risk Class
    Class 2
  • Event Number
    Z-1072-2009
  • Event Initiated Date
    2008-12-24
  • Event Date Posted
    2009-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77099
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    The marker band may detach from the sheath and a clinical failure could result in an embolism.
  • Action
    The firm initiated the recall on December 24, 2009 and notified consignees via "Urgent Company Initiated Medical Device Recall - Immediate Action Required" letters which explain the reason for the recall and request the affected product be returned to the Boston Scientific Corporation Distribution Center. An amendment letter with two additional Convoy Advanced Delivery Sheath Kit models (M0045748ST0 and M0045749ST0) was sent to affected customers on January 27, 2009. Direct questions about this recall to your local Sales Representative.

Device

Device Recall Convoy Soft Tip Sheath Multipurpose Introducing Sheath Kits
  • Model / Serial
    Batch Numbers: 5660, 5662, 5665, 5671, 5661, 5663, 5670 and 5676 and Batch Numbers: S17665, S2053, S1827, S2283,S2382,S20023, S2100, S1917,S2314,S2200,S21439, S2144,S1956,S2315,S2002,S22763, S2240, S2027,S2390,S2305,S2382, S2276,S2053,S2520,S23827,S17392, S2305,S2077,S2559,S1701,S18274, S2386,S2100,S2588,S1701,S19033, S2542,S2121,S2637,S2421,S19561, S1734,S2240,S1918,S20021, S1746, S2280, S2305, S1823 1 S2016 8 S2221 8 S2310 6 S2582 7 S1823 2 S2029 6 S2223 0 S2310 7 S2589 0 S1827 6 S2037 0 S2223 1 S2310 8 S2600 7 S1847 2 S2043 7 S2223 2 S2342 8 S2613 9 S1864 9 S2043 8 S2229 5 S2346 4 S2615 7 S1869 6 S2043 9 S2229 6 S2346 5 S2615 8 S1870 9 S2044 0 S2229 7 S2360 6 S2621 5 S1874 9 S2049 5 S2248 5 S2360 7 S2632 8 S1884 4 S2071 5 S2250 5 S2369 9 S2632 9 S1888 4 S2071 6 S2250 8 S2371 7 S2635 9 S1892 1 S2082 1 S2274 1 S2405 8 S2641 5 S1895 8 S2099 6 S2274 2 S2413 0 S2648 1 S1899 2 S2099 7 S2277 5 S2413 1 S1899 3 S2100 5 S2277 6 S2447 3 S1899 4 S2102 0 S2279 4 S2478 4 S1899 5 S2102 1 S2282 6 and S2493 3.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: || M00456600, || M00456610, || M00456620, || M00456630, || M00456650, || M00456700, || M00456710 and || M00456760. || Manufactured by Thomas Medical Products, Inc. || Product is intended for use to facilitate the percutaneous introduction of various types of cardiovascular catheters into either the right or left side of the heart. The sheath may be exchanged and used for left sided placement, after transseptal puncture has first been obtained by another sheath.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Manufacturer Address
    Boston Scientific Corp, 150 Baytech Dr, San Jose CA 95134-2302
  • 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