St. Jude Medical Daig Division Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc., Minnetonka, MN 55345-2126, USA. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc., Minnetonka, MN 55345-2126, USA.
Brand
St. Jude Medical Daig Division
Lot Codes / Batch Numbers
Lot number 1146548
Products Sold
Lot number 1146548
St. Jude Medical Daig Division is recalling Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. due to Mispackaging-Some Angio-Seal 6F STS Vascular Closure Devices from Lot no. 1146548 have been incorrectly packaged with a 0.035' guidewire instead of a . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mispackaging-Some Angio-Seal 6F STS Vascular Closure Devices from Lot no. 1146548 have been incorrectly packaged with a 0.035' guidewire instead of a 0.032' guidewire.
Recommended Action
Per FDA guidance
Letters were delivered to the hospitals and/or doctors in possession of the product instructing them to return it.
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 noticePage updated: Jan 10, 2026