Events

Rappel de Device Recall Percutaneous Access Set

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 Corporation.

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
    79424
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1104-2018
  • Date de mise en oeuvre de l'événement
    2017-12-12
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162286
  • 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
    Catheter, nephrostomy, general & plastic surgery - Product Code GBO
  • Cause
    Certain malecot nephrostomy catheters are breaking at the mid-shaft bond during use.
  • Action
    The firm, Boston Scientific, sent an "Urgent Medical Device Product Removal - Immediate Action Required" letter dated 12/12/2017 to its consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to: identify and remove all affected batches from your inventory; immediately discontinue use of and segregate the affected product, and return it to Boston Scientific. Distributors were notified that this removal is to the customer level and asked to notify any customers who received affected product. Consignees were asked to complete and return the Replay Verification Tracking Form (even if you do not have any product to return) via email: BSCFieldActionCenter@bsci.com or Fax to: Field Action Center at 1-866-213-1806. If you have any questions, your local Sales Representative can answer any questions that you may have regarding this removal or contact Vice President , Regulatory Affairs at 508-683-4398 or email: Donna.Gardner@bsci.com or BSCFieldActionCenter@bsci.com.

Device

Device Recall Percutaneous Access Set
  • Modèle / numéro de série
    Expiration Date Range: 12/10/2017 - 10/29/2021; Batch: 16602757 17989189 19103005 16632804 18000051 19156402 16668232 18071028 19272679 16687725 18187908 19323232 16701905 18238926 19338380 16725748 18312539 19374391 16746021 18347202 19419431 16768170 18403711 19510783 16769687 18453529 19543444 16791047 18467224 19596296 16813326 18511816 19622910 16861185 18522401 19652445 16886796 18631119 19672586 16911889 18702248 19824542 16918770 18702249 19884752 16931022 18705836 20001153 16931071 18780195 20091268 16964525 18800088 20118753 17143046 18818625 20198261 17227380 18820391 20288613 17399143 18900337 20321757 17446684 18900338 20477761 17604237 18955686 20753764 17659535 18977772 20789373 17670349 19006930 21009191 17710577 19087159 21046808 17766030 19097822 21316321 17826778
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) in the following: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, including the District of Columbia and Puerto Rico; and countries of: Argentina, Bolivia, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Peru, Venezuela, Australia, Bangladesh, Botswana, China, Kuwait, Lebanon, Macau, Malaysia, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Turkey, United Arab Emirates, and Zimbabwe.
  • Description du dispositif
    Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 || The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • 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