Recall Z-1435-2013— Heart Sync, Inc

Name: FDA recall Z-1435-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-26

Class II · Terminated

Class II FDA medical device recall by Heart Sync, Inc, initiated 2013-04-26, terminated 2014-04-16. It names one FDA 510(k) clearance: K080421. 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: 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..

Recalling firm: Heart Sync, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-04-26
Terminated: 2014-04-16
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K080421 — HEART SYNC, MODELS C-100 AND T-100Heart Sync, LLC·cleared 2008-02-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.