Heart Sync, Inc: Medical Device Recall in 2013 - (Recall #: Z-1434-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.

Product Classification:

Class II

Date Initiated: April 26, 2013

Date Posted: June 5, 2013

Recall Number: Z-1434-2013

Event ID: 65085

Reason for Recall:

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.

Status: Terminated

Product Quantity: 17180 units for all part numbers

Code Information:

Part number : C100-Physio and Lot numbers: Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01

Distribution Pattern:

Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.

Voluntary or Mandated:

Voluntary: Firm initiated