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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 2 of 5

Device	Model / Reference	Registries	Class	Status
Supreme™	401474	FDA UDI	Class II	Active
Supreme™	401979	FDA UDI	Class II	Active
Brk™	G407210	FDA UDI	Class II	Active
Livewire™	401939	FDA UDI	Class II	Active
Sjm™	401758	FDA UDI	Class II	Active
HydroSteer™	405071	FDA UDI	Class II	Unknown
Supreme™	401436	FDA UDI	Class II	Active
Response™	401137	FDA UDI	Class II	Active
Angio-Seal™	VIP	FDA UDI	Class III	Unknown
Response™	401156	FDA UDI	Class II	Active
Safire™	402570	FDA UDI	Class III	Active
HydroSteer™	405070	FDA UDI	Class II	Unknown
Response™	401226	FDA UDI	Class II	Active
Pacel™	401773	FDA UDI	Class II	Active
Supreme™	401956	FDA UDI	Class II	Active
Safire™	402810	FDA UDI	Class III	Active
Response™	401132	FDA UDI	Class II	Active
Livewire™	401991	FDA UDI	Class II	Active
HydroSteer™	405079	FDA UDI	Class II	Unknown
Safire™	402809	FDA UDI	Class III	Active
Response™	401392	FDA UDI	Class II	Active
Supreme™	401430	FDA UDI	Class II	Active
Supreme™	401993	FDA UDI	Class II	Active
Livewire™	402206	FDA UDI	Class III	Active
Response™	401282	FDA UDI	Class II	Active
HydroSteer™	405059	FDA UDI	Class II	Unknown
HydroSteer™	405065	FDA UDI	Class II	Active
Angio-Seal™	Evolution™	FDA UDI	Class III	Unknown
HydroSteer™	405072	FDA UDI	Class II	Unknown
HydroSteer™	405064	FDA UDI	Class II	Active
Response™	401972	FDA UDI	Class II	Active
Supreme™	401957	FDA UDI	Class II	Active
Response™	401357	FDA UDI	Class II	Active
Supreme™	402004	FDA UDI	Class II	Active
Response™	401318	FDA UDI	Class II	Active
Pacel™	401763	FDA UDI	Class II	Active
Supreme™	401892	FDA UDI	Class II	Active
Livewire™	401786	FDA UDI	Class II	Active
HydroSteer™	405081	FDA UDI	Class II	Unknown
HydroSteer™	405077	FDA UDI	Class II	Unknown
Brk™	407206	FDA UDI	Class II	Active
Supreme™	401448	FDA UDI	Class II	Active
Response™	401971	FDA UDI	Class II	Active
Safire™	402814	FDA UDI	Class III	Active
Response™	401975	FDA UDI	Class II	Active
Livewire™	402152	FDA UDI	Class III	Active
Angio-Seal™	STS Plus	FDA UDI	Class III	Unknown
Response™	401386	FDA UDI	Class II	Active
Supreme™	401982	EUDAMEDFDA UDI	Class II	Active
Response™	401206	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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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.