Events

Rappel de SQRX Model 1010 Subcutaneous Pulse Generator

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
    72225
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0232-2016
  • Date de mise en oeuvre de l'événement
    2015-09-17
  • Date de publication de l'événement
    2015-11-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140276
  • 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
    Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
  • Cause
    Devices shipped to us in dual-channel rather than us approved single-channel rf telemetry communication mode. while this does not impact therapy delivery of device; this can impact likelihood of successfully establishing telemetry during first scan of device when using a single-channel programmer. telemetry can be established with additional scans; once established no further difficulty is expecte.
  • Action
    One consignee was contacted via a Boston Scientific "Medical Device Retrieval" letter dated September 17, 2015. The letter was addressed to Hospital Administrator. The letter described the problem and the product involved in the recall. Informed consignee that their local Boston Scientific sales representative will be retrieving the product form their inventory. For questions they can contact their local sales representative or Boston Scientific Technical service at 1-800-227-3422. A second Boston Scientific "Important Medical Device Information" letter dated October 2015 was hand delivered to physicians starting on 10/15/2015. The letter described the problem and provided information on Clinical Considerations, Affected Population, Recommendations and Further Information. For questions they can contact their Boston scientific representative or the Americas Technical service at 1-800-227-3422.

Device

SQRX Model 1010 Subcutaneous Pulse Generator
  • Modèle / numéro de série
    A019995 A020132 A020240
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the US to MA and PR.
  • Description du dispositif
    Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). || Intended to provide defibrillation therapy.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • 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