CLASS II Device recall · Reported 5 Jun 2013 · FDA Enforcement Report
C100-Physio Radiotransparent Defibrillation Electrodes recalled
Heart Sync is recalling Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic, distributed nationwide in the US. The recall was initiated on 26 Apr 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1434-2013
- FDA event ID
- 65085
- Recalling firm
- Heart Sync, Ann Arbor, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Apr 2013
- FDA classified
- 30 May 2013
- Reported
- 5 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Pacemakers & Defibrillators
Timeline
| 26 Apr 2013 | Recall initiated by company | |
| 30 May 2013 | Classified by FDA | +34 days |
| 5 Jun 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.
Nationwide AlabamaGeorgiaMassachusettsMichiganMinnesotaNorth CarolinaNorth DakotaOhioPennsylvaniaSouth DakotaTexasVirginiaVermont
Questions about this recall
Is C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible recalled?
Yes. Heart Sync recalled C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible on 26 Apr 2013. The recall is Class II and its status is Terminated. Recall number Z-1434-2013.
Why was it recalled?
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.
Which lots are affected?
Part number : C100-Physio and Lot numbers: Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01
Where was it sold?
Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Heart Sync
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Adult/Child Radiotransparent Electrode recalled by Heart Sync | Heart Sync | Device Malfunction | Nationwide |
| Device | CLASS I | Adult Radiotranslucent Electrode recalled by Heart Sync | Heart Sync | Device Malfunction | Nationwide |
| Device | CLASS I | Adult/Child Radiotranslucent Electrode recalled by Heart Sync | Heart Sync | Device Malfunction | Nationwide |
| Device | CLASS I | Adult Radiotransparent Electrode recalled by Heart Sync | Heart Sync | Device Malfunction | Nationwide |
| Device | CLASS I | Adult Radiotranslucent Electrode recalled by Heart Sync | Heart Sync | Device Malfunction | Nationwide |
Other Pacemakers & Defibrillators recalls
All 494| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DermaV Laser System recalled by Lutronic | Lutronic | Other | Nationwide |
| Device | CLASS II | Convenience kits containing select SKUs of Polycarbonate recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled | Medline Industries | Device Malfunction | Nationwide |