St. Jude Medical Daig Division 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 excha Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 excha
Brand
St. Jude Medical Daig Division
Lot Codes / Batch Numbers
Lot number range: 1169725 to 1181488 EXPANDED RECALL additional lot numbers are: 1182741, 1182742, 1182743, 1182744, 1182745, 1184211, 1185314, 1186554, 1186557.
Products Sold
Lot number range: 1169725 to 1181488 EXPANDED RECALL additional lot numbers are: 1182741, 1182742, 1182743, 1182744, 1182745, 1184211, 1185314, 1186554, 1186557.
St. Jude Medical Daig Division is recalling St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308 (Australia). Sterile EO. St. due to St Jude Medical has determined that a limited number of Agilis Steerable Introducers manufactured in late 2005 are susceptible to the hemostasis hub l. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, NE, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI, DC
Page updated: Jan 10, 2026