Events

Retiro De Equipo (Recall) de LAPBAND Adjustable Gastric Band System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Allergan.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    57094
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0418-2011
  • Fecha de inicio del evento
    2010-09-16
  • Fecha de publicación del evento
    2010-11-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95382
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Implant, intragastric for morbid obesity - Product Code LTI
  • Causa
    In a lap-band system adjustment, failure to inject the needle perpendicular to the access port septum, as described in directions for use, may lead to port damage, resulting in subsequent port leakage. leakage results in deflation of the lap-band to its widest, open position requiring a procedure to replace the port. the patient may have symptoms of reduced satiety and increased appetite. stalling.
  • Acción
    Allergan sent an URGENT FIELD CORRECTIVE ACTION letter dated September 15, 2010, to all affected customers. The recall communication was initiated on 09/16/2010 when the firm begin forwarding Customer letters with attached current Directions for Use distributed via Federal Express, with tracking verification provided by Federal Express, to the direct consignees. The Customer letters informed consignees of the products affected, description of the Issue, clinical implications and firm recommendations. Customers were instructed to follow the Directions for Use for inserting the needle. Customers were instructed to report any malfunction or adverse event related to the device to Allergan Product Support at 1-800-624-4261 ext. 5972 or 1-805-961-5972 and FDA's Medwatch Program (1-800-FDA-1088 or www.fda.gov/medwatch). For questions, consignees were instructed to contact their Allergan field representative or contact Allergan Product Support at 1-800-624-4261.

Device

LAPBAND Adjustable Gastric Band System
  • Modelo / Serial
    All Lot Numbers for the listed Product Codes are affected by this recall.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, AND WY
  • Descripción del producto
    LAP-BAND Adjustable Gastric Band System; Product codes: || B-2105 (ACCSS PRT II KIT (0-10CC) US), || B-2106 (ACCESS PRT II KIT (0-14CC) US), || B-2210 (LP-BND SYS, 9.75, STER, US), || B-2215 (LAP-BAND 9.75 W/ACC PRT II US), || B-2220 (LP-BND SYS, 10.0, STER, US), || B-2225 (LAP-BND 10.0,ACCESS PORT II,US), || B-2255 (LAP-BAND VG W/ACS PORT II (US), || B-2260 (LP-BND AP STANDARD SYS, W ACC PRT II), || B-2265 (LP-BND AP LG SYS, W/ACC PRT II); || The Lap-Band System is a long-term implantable device intended to induce weight loss in morbidly obese patients by limiting food consumption restrictive and satiating, rather than malabsorptive). The device is surgically implanted, using either a laparoscopic or open procedure, to create a restricted opening (stoma) and a small gastric pouch to limit food consumption and induce early satiety. The main components of the device are the silicone elastomer band, access port. and kink-resistant tubing used to connect the other two components. The inner surface of the silicone band, which is placed around the stomach, is inflatable and connected by the tubing to the access port (a remote injection site. The access port is implanted on, or attached to, the rectus muscle to permit non-surgical, percutaneous adjustments to the band and thus, the stoma diameter, using sterile saline.
  • Manufacturer
    Allergan

Manufacturer

Allergan