Events

Recall of St. Jude Medical AGILIS Steerable Catheter Introducer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by St. Jude Medical / Daig Division.

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
    35300
  • Event Risk Class
    Class 2
  • Event Number
    Z-1086-06
  • Event Initiated Date
    2006-04-14
  • Event Date Posted
    2006-06-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45749
  • 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
    Catheter Introducer - Product Code DYB
  • Reason
    St jude medical has determined that a limited number of agilis steerable introducers manufactured in late 2005 are susceptible to the hemostasis hub leaking or separating from the handle. the risks that exist are related to the loss of hemostasis through the agilis introducer and/or the possibility of air or foreign body being introduced into the patient with resultant embolism.
  • Action
    A Field Action Notification, dated 04/13/06, was sent to hospital's Electrophysiology labs (cath labs) and to physicians. This Notification describes the issue, the risk to patient, identifies lot numbers of product affected and states that a SJM Rep will be contacting them soon. The SJM Reps visited the hospitals to verify they received the notification and retrieve affected product. Replacement product will be provided at no charge. EXPANDED RECALL A Field Action Notification, dated 06/01/06, was sent to hospital's Electrophysiology labs (cath labs) and to the physicians who reported a problem with the device. This Notification describes the issue, risk to patients, identifies lot numbers and states that a SJM Representative will be contacting them soon to facilitate the return of product. Replacement product will be offered at no charge. The physician notification, dated 06/01/2006, describes the issue, the risk, lot number affected and informs them that a notification has been sent to the hospitals EP Lab.

Device

St. Jude Medical AGILIS Steerable Catheter Introducer
  • Model / Serial
    Lot number range: 1169725 to 1181488 EXPANDED RECALL additional lot numbers are: 1182741, 1182742, 1182743, 1182744, 1182745, 1184211, 1185314, 1186554, 1186557.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide- USA states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV. ---Foreign includes: Austria, Belgium, Denmark, France, Germany, Great Britain, Italy, Lichtenstein, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, United Kingdom
  • Product Description
    St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308 (Australia). Sterile EO. St. Jude Medical Daig Division, Inc., Minnetonka, MN 55345-2126 USA. This St. Jude Medical (SJM) Agilis Steerable Catheter Introducer Set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise >than or equal to 180-degrees and counter-clockwise >than or equal to 90-degrees. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization. EXPANDED RECALL The Reorder number affected by the recall expansion is 408304.
  • Manufacturer
    St. Jude Medical / Daig Division

Manufacturer

St. Jude Medical / Daig Division
  • Manufacturer Address
    St. Jude Medical / Daig Division, 14901 Deveau Pl, Minnetonka MN 55345-2126
  • Source
    USFDA