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HEART SYNC INC

Last updated May 24, 2026

Information

Country: US
Address: —
Website: heartsync.net
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 800.828.4681
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 041356039

Catalogue (33)

Device	Model / Reference	Registries	Class	Status
Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes	Sterile-C100-Zoll	FDA UDI	Class III	Unknown
Adult/Child, radiolucent, defib electrodes w/ Physio connector	T100AC-PHYSIO	FDA UDI	Class II	Active
Adult/Child, radiolucent, leads out, defib electrodes w/ Physio connector	T100LOAC-PHYSIO	FDA UDI	Class II	Active
Adult/Child, radiotransparent, defib electrodes w/ Phillips connector	C100AC-PHILIPS	FDA UDI	Class II	Active
Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes	Sterile-C100-Physio	FDA UDI	Class III	Unknown
Pediatric (infant), radiolucent, defib electrodes w/ Philips connector	PEDIATRIC-PHILIPS	FDA UDI	Class II	Active
Adult/Child, radiotransparent, defib electrodes with increased adhesive surface	C300AC-PHYSIO	FDA UDI	Class II	Active
Pediatric (infant), radiolucent, defib electrodes w/ Anderson connector	PED-100	FDA UDI	Class II	Active
Adult/Child, radiotransparent, leads out, defib electrodes w/ Phillips connector	C100LOAC-PHILIPS	FDA UDI	Class II	Active
Adult/Child, radiolucent, defib electrodes w/ Zoll connector	T100AC-ZOLL	FDA UDI	Class II	Active
Adult/Child, radiolucent, defib electrodes w/ Phillips connector	T100AC-PHILIPS	FDA UDI	Class II	Active
Adult/Child, radiolucent, leads out, defib electrodes w/ Zoll connector	T100LOAC-ZOLL	FDA UDI	Class II	Active
Adult/Child, radiotransparent, defib electrodes with large back-posterior pad w/	C200AC-PHYSIO	FDA UDI	Class II	Active
Adult/Child, radiotransparent, leads out, defib electrodes w/ Physio connector	C100LOAC-PHYSIO	FDA UDI	Class II	Active
Heart Sync Adult Radio Transparent Multi Function Electrodes	C100AC-Physio	FDA UDI	Class II	Active
Adult/Child, radiolucent, defib electrodes w/ Anderson connector	T100AC	FDA UDI	Class II	Active
Adult/Child, radiotransparent, defib electrodes with large back-posterior pad w/	C200AC-PHILIPS	FDA UDI	Class II	Active
Adult/Child, radiotransparent, leads out, defib electrodes w/ Zoll connector	C100LOAC-ZOLL	FDA UDI	Class II	Active
Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes	Sterile-C100	FDA UDI	Class III	Unknown
Adult/Child, radiolucent, defib electrodes w/ 10 foot lead wire with Zoll connec	T100AC-ZOLL-10	FDA UDI	Class II	Active
Adult/Child, radiotransparent, defib electrodes with large back-posterior pad w/	C200AC-ZOLL	FDA UDI	Class II	Active
Pediatric (infant), radiolucent, defib electrodes w/ Zoll connector	PEDIATRIC-ZOLL	FDA UDI	Class II	Active
Heart Sync Adult/Child Radio Transparent Multi Function Electrodes	C100LOAC	FDA UDI	Class II	Active
Heart Sync T-CardiacSci-AED™ Pads	T100-CS	FDA UDI	Class III	Active
Adult/Child, radiotransparent, defib electrodes w/ Zoll connector	C100AC-ZOLL	FDA UDI	Class II	Active
Pediatric (infant), radiolucent, defib electrodes w/ Physio connector	PEDIATRIC-PHYSIO	FDA UDI	Class II	Active
Adult/Child, radiolucent, leads out, defib electrodes w/ Phillips connector	T100LOAC-PHILIPS	FDA UDI	Class II	Active
Heart Sync Adult/Child Radio Transparent Multi Function Electrodes	C100AC	FDA UDI	Class II	Active
Adult/Child, radiotransparent, defib electrodes with increased adhesive surface	C300AC-ZOLL	FDA UDI	Class II	Active
Adult/Child, radiotransparent, defib electrodes with increased adhesive surface	C300AC-PHILIPS	FDA UDI	Class II	Active
Heart Sync, Models C-100 And T-100	K080421	FDA 510(k)	Class III	Active
Heart Sync Pediatric, Model Ped-100	K081442	FDA 510(k)	Class II	Active
Heart Sync Pediatric Physio Aed Pad	K120536	FDA 510(k)	Class III	Active

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FDA Recalls (11)

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

Date	Recall No.	Class	Status	Reason
Nov 11, 2014	Z-0583-2015	—	terminated	Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the
Nov 11, 2014	Z-0584-2015	—	terminated	Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the
Nov 11, 2014	Z-0585-2015	—	terminated	Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the
Nov 11, 2014	Z-0586-2015	—	terminated	Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the
Nov 11, 2014	Z-0587-2015	—	terminated	Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the
Apr 26, 2013	Z-1435-2013	—	terminated	On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.
Apr 26, 2013	Z-1434-2013	—	terminated	On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.
Dec 17, 2010	Z-1371-2011	—	terminated	The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not open package until immediately prior to using electrodes. and Electrodes may dry out when removed from packaging and exposed to air.
Dec 17, 2010	Z-1372-2011	—	terminated	The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not open package until immediately prior to using electrodes. and Electrodes may dry out when removed from packaging and exposed to air.
Dec 5, 2008	Z-1950-2011	—	terminated	The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration.
Dec 5, 2008	Z-1951-2011	—	terminated	The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration.