St. Jude Medical, Daig Division, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 7
At a glance
Market reach
- United States
- FDA recalls
What St. Jude Medical, Daig Division, Inc. makes
The company manufactures electrophysiology catheters, including the APEEL CS PLUS Catheter Delivery System for ablation procedures and the Agilis Steerable Catheter Introducer for guiding diagnostic and therapeutic catheters within the heart.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 7 recalls initiated by St. Jude Medical, Daig Division, Inc., the earliest on 2004-08-04 and the most recent on 2006-10-05. By recorded status: 7 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 5 Oct 2006 Z-0535-2007 Unclassified (pre-2012) Terminated Limited number of FastCath Transseptal Catheter Introducers (REF #406850) are susceptible to the irrigation extension tube on the side port becoming disconnected when a pull force is applied.
- 7 Jun 2006 Z-0157-2007 Unclassified (pre-2012) Terminated The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038'' guidewire vs. the required 0.035'' guidewire.
- 14 Apr 2006 Z-1086-06 Unclassified (pre-2012) Terminated 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.
Full distribution text
2005
- 20 Sep 2005 Z-0125-06 Unclassified (pre-2012) Terminated A lot of product contains a 6F Obturator with a hub that is incorrectly marked as 5 instead of the appropriate 6. The Obturator is correctly sized (6F) per the labeling on both the sterile bag and shelf carton.
- 22 Aug 2005 Z-0677-06 Unclassified (pre-2012) Terminated 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.
2004
- 4 Aug 2004 Z-1425-04 Unclassified (pre-2012) Terminated St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the inner sheath. Subsequent testing of Telesheath inventory at St. Jude Medical indicated that the side arm from the inner sheath can detach during routine handling and manipulation, and occurs on a random basis.
- 4 Aug 2004 Z-1426-04 Unclassified (pre-2012) Terminated St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the inner sheath. Subsequent testing of Telesheath inventory at St. Jude Medical indicated that the side arm from the inner sheath can detach during routine handling and manipulation, and occurs on a random basis.
Frequently asked questions
How many devices does St. Jude Medical, Daig Division, Inc. have in the registry?
The registry currently lists 2 devices for St. Jude Medical, Daig Division, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list St. Jude Medical, Daig Division, Inc.'s devices?
Among its 2 most recently registered devices, St. Jude Medical, Daig Division, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do St. Jude Medical, Daig Division, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for St. Jude Medical, Daig Division, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for St. Jude Medical, Daig Division, Inc.?
FDA recall records list 7 recalls initiated by St. Jude Medical, Daig Division, Inc., the most recent initiated on 5 Oct 2006. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from St. Jude Medical, Daig Division, Inc. in the registry?
The most recently registered devices listed for St. Jude Medical, Daig Division, Inc. include APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582 and AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304.