Vermed — Class II medical device recall Z-1435-2013

Terminated recall by Heart Sync, Inc, reported 2013-06-05, distributed in AL, GA, MA, MI, MN, NC, ND, OH…. On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in

Recall number	`Z-1435-2013`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Heart Sync, Inc, Ann Arbor, MI, United States
Recall initiated	2013-04-26
Classified	2013-05-30
Reported by FDA	2013-06-05
Terminated	2014-04-16
Distributed	AL, GA, MA, MI, MN, NC, ND, OH, PA, SD, TX, VA, VT
Countries outside the US	KR
Quantity	17,180 units
Lot numbers	`Y012413-02`, `Y022013-01`, `Y032113-01`, `Y100112-02`, `Y102212-03`, `Y121312-18`
Model numbers	`D304`

Product

Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1435-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.