St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308 (Australia). Sterile EO. St. Jude Medical Daig Di
FDA device recall Z-1086-06 · posted 2006-06-03 · Terminated
Recall details
- Recalling firm
- St. Jude Medical / Daig Division
- Reason for recall
- 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 taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 2,489 EXPANDED RECALL an additional 281 devices
- 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,
- Date initiated
- 2006-04-14
- Date posted
- 2006-06-03
- Date terminated
- 2007-04-01
- Location
- Minnetonka, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304 (K042623) | St. Jude Medical, Daig Division, Inc. | 2005-01-27 |