Events

Rappel de Device Recall Convoy Soft Tip Sheath Multipurpose Introducing Sheath Kits

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Boston Scientific Corp.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    50771
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1072-2009
  • Date de mise en oeuvre de l'événement
    2008-12-24
  • Date de publication de l'événement
    2009-04-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-04-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77099
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Introducer, catheter - Product Code DYB
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    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
  • Adresse du fabricant
    Boston Scientific Corp, 150 Baytech Dr, San Jose CA 95134-2302
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “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