FDA Devices recall · Reported June 5, 2013
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.
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 d…
Heart Sync, Inc recalled Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic … - a moderate-severity action.
Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic … was recalled by Heart Sync, Inc in June 5, 2013. Reason: On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used i…. Check the official notice for the remedy. Verify recall #Z-1434-2013 with the FDA Devices before acting.
The recall
Heart Sync, Inc issued this moderate-severity FDA Devices recall-On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used i….
- Moderate
- severity level
- 17K units
- affected scope
- Class II
- classification
- June 5, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1434-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1434-2013 |
| Date reported | June 5, 2013 |
| Date initiated | April 26, 2013 |
| Recalling firm | Heart Sync, Inc |
| Firm location | Ann Arbor, MI |
| Affected scope | 17180 units for all part numbers |
| Distribution | Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1434-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026