Z-0462-2015Class I

CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart...

Name: Z-0462-2015 CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart...
Creator: ConMed Corporation
Published: 2014-11-06
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2014-11-06 / Terminated / root cause: design

FDA source

ConMed Corporation began a recall of CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use... on 2014-11-06. FDA classified it as Class I and gives the reason as "Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0462-2015
Classification: Class I
Status: Terminated
Initiated: 2014-11-06
Posted: 2014-12-04
Terminated: 2017-10-30
Recalling firm: ConMed Corporation
Product: CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.
Product code: LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Reason for recall: Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.
Root cause tag: design
FDA root cause: Device Design
Action: ConMed sent an Urgent Device Correction letter dated November 16, 2014, to all affected consignees via UPS Next Day Air. The letter instructed consignees to notify all end users of the correction. For questions or additional information, consignees were instructed to contact ConMed at 1-727-399-5276 or by e-mail at [email protected]. International notices were sent via UPS Priority or equivalent by November 19, 2014.
Quantity in commerce: 174,610 (168,090 US and 6,520 OUS) in total.
Distribution: Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.
Product codes and lots: All Lot Codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0462-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0454-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-04
Z-0455-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-04
Z-0456-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-04
Z-0457-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-04
Z-0458-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-04
Z-0459-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-04
Z-0460-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-04
Z-0461-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-04
Z-0462-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-04

Product code LDD

K964469Class II700-F Series Stimulation ElectrodesCardiotronics Systems, Inc. / cleared 1996-12-11

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)