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ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

Last updated May 24, 2026

What ST. JUDE MEDICAL CARDIOVASCULAR DIVISION makes

The company manufactures single-use and reusable catheters for cardiac procedures, including percutaneous mapping, radio-frequency ablation, transseptal access, and temporary pacing. It also produces guidewires for cardiac and peripheral vascular interventions, as well as electrocardiographic adaptors and pacing balloons. Electrical connection cables for medical devices are part of its reusable product line.

These devices are classified under FDA’s Class II and Class III regulatory categories and are listed in the FDA’s UDI (Unique Device Identification) database. The company operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: sjm.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(855)478-5833
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 040960379

Catalogue (233)

Page 1 of 5

Device	Model / Reference	Registries	Class	Status
Supreme™	401443	FDA UDI	Class II	Active
HydroSteer™	405082	FDA UDI	Class II	Active
Supreme™	401433	FDA UDI	Class II	Active
Livewire™	402151	FDA UDI	Class III	Active
HydroSteer™	405056	FDA UDI	Class II	Active
HydroSteer™	405066	FDA UDI	Class II	Unknown
Response™	401309	FDA UDI	Class II	Active
Supreme™	401893	FDA UDI	Class II	Active
Livewire™	401917	FDA UDI	Class II	Active
Sjm™	401748	FDA UDI	Class II	Active
Pacel™	401766	FDA UDI	Class II	Active
Livewire™	401652	FDA UDI	Class II	Active
Brk-1™	G407212	FDA UDI	Class II	Active
Response™	401154	FDA UDI	Class II	Active
Response™	401150	FDA UDI	Class II	Active
Pacel™	401767	FDA UDI	Class II	Active
Pacel™	401761	FDA UDI	Class II	Active
Supreme™	401983	FDA UDI	Class II	Active
Supreme™	401470	FDA UDI	Class II	Active
Pacel™	401769	FDA UDI	Class II	Active
Response™	401133	FDA UDI	Class II	Active
Livewire™	401940	FDA UDI	Class II	Active
Pacel™	401771	FDA UDI	Class II	Active
Supreme™	402010	FDA UDI	Class II	Active
Response™	401278	FDA UDI	Class II	Active
Supreme™	401860	FDA UDI	Class II	Active
Supreme™	401450	FDA UDI	Class II	Active
Livewire™	402150	FDA UDI	Class III	Active
Supreme™	401966	FDA UDI	Class II	Active
Sjm™	401760	FDA UDI	Class II	Active
Supreme™	401985	FDA UDI	Class II	Active
Supreme™	401891	FDA UDI	Class II	Active
Livewire TC™	A402580	FDA UDI	Class III	Active
Livewire™	401575	FDA UDI	Class II	Active
Brk-1™	G407216	FDA UDI	Class II	Active
Supreme™	401444	FDA UDI	Class II	Active
Safire™	402813	FDA UDI	Class III	Active
Supreme™	401871	FDA UDI	Class II	Active
HydroSteer™	405062	FDA UDI	Class II	Active
Response™	401317	FDA UDI	Class II	Active
Supreme™	401876	FDA UDI	Class II	Active
Safire™	402806	FDA UDI	Class III	Active
Safire™	402554	FDA UDI	Class III	Active
Supreme™	401986	FDA UDI	Class II	Active
Livewire™	402273	FDA UDI	Class III	Active
Supreme™	401862	FDA UDI	Class II	Active
Livewire TC™	402518	FDA UDI	Class III	Active
HydroSteer™	405078	FDA UDI	Class II	Unknown
Livewire™	401990	FDA UDI	Class II	Active
Supreme™	401984	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (7)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

St. Jude Medical Cardiovascular Division has seven recall records initiated between June 5, 2008, and January 26, 2011, all of which are recorded as terminated. The recalls involve the MitraXs Self Adjusting Atrial Retractor (all batches and model numbers), a mislabelled Livewire TC Ablation Catheter (one lot), and potential structural failures in the Shaft or hub assembly of an unspecified introducer device. The reasons cited include product distribution prior to full assessment, incorrect tip size labeling, and potential separation or material defects that could affect device integrity.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jan 26, 2011	Z-1370-2011	—	terminated	St. Jude Medical Cardiovascular Division is conducting a voluntary recall of all batches and model numbers of the MitraXs Self Adjusting Atrial Retractor. St. Jude Medical has been distributing this product since their acquisition of CLR in late 2008. They have determined that some distributed batches have very small burrs on the polycarbonate material at the distal edge. As these burrs may
Jun 28, 2010	Z-2179-2010	—	terminated	Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak around the Introducer hub and strain relief.
Jun 28, 2010	Z-2181-2010	—	terminated	Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak around the Introducer hub and strain relief.
Jun 28, 2010	Z-2182-2010	—	terminated	Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak around the Introducer hub and strain relief.
Jun 28, 2010	Z-2180-2010	—	terminated	Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak around the Introducer hub and strain relief.
Jun 28, 2010	Z-2178-2010	—	terminated	Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak around the Introducer hub and strain relief.
Jun 5, 2008	Z-2313-2008	—	terminated	St. Jude Medical has initiated a recall of one lot of Livewire TC" Ablation Catheter. The product was mis-labelled as having an 8 mm tip instead of 4 mm tip. This could potentially result in elevated temperatures and formation of coagulum at the tip electrode. If this coagulum were to detach from the product, the worst case this could potentially result in embolization.