Z-1435-2013Class II

Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible...

Name: Z-1435-2013 Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible...
Creator: Heart Sync, Inc
Published: 2013-04-26
License: https://open.fda.gov/license/

Graphic Controls Acquisition Corp.dba Nissha Medical Technologies / initiated 2013-04-26 / Terminated / root cause: manufacturing process

FDA source

Heart Sync, Inc began a recall of Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in... on 2013-04-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1435-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-26
Posted: 2013-05-30
Terminated: 2014-04-16
Recalling firm: Graphic Controls Acquisition Corp.dba Nissha Medical Technologies
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.
Product code: LDF Electrode, Pacemaker, Temporary
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: HeartSync sent an URGENT MEDICAL DEVICE RECALL notification letter dated April 26, 2013, to all consignees of Heart Sync for C100-Physio Radiotransparent Defrillation Electrodes. On April 29, 2013, an URGENT MEDICAL DEVICE RECALL notification was sent to Vermed Inc for the D304 Defrillation Electrodes . The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the affected product to the firm for full credit. Customers were asked to complete the form and send back via fax to 734-213-5640 or call 734-213-5530. For questions regarding this recall call 734-213-5530. .
Quantity in commerce: 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.
Product codes and lots: Part Number: D304 and lot numbers:Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1435-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1434-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-30
Z-1435-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-30

Product code LDF

K080421Class IIIHeart Sync, Models C-100 and T-100Heart Sync, LLC / cleared 2008-02-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)