—#117902

Product

PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K014209
Affected lot / code info: Lot Code Y092012-21, Manufacture Date 10/10/2012; Lot Code Y102612-12, Manufacture Date 11/17/2012; Lot Code Y110912-20, Manufacture Date 11/30/2012; Lot Code Y112912-10, Manufacture Date 12/22/2012; Lot Code Y121312-19, Manufacture Date 01/03/2013; Lot Code Y011013-13, Manufacture Date 01/29/2013; Lot Code Y012513-02, Manufacture Date 02/12/2013; Lot Code Y020713-05, Manufacture Date 02/26/2013; Lot Code Y021413-03, Manufacture Date 03/07/2013; Lot Code Y030113-04, Manufacture Date 03/23/2013

Why it was recalled

ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient.

Root cause (FDA determination)

Component design/selection

Action the firm took

ConMed sent a URGENT: Field Safety Notice letter dated May 3, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to please review your inventory for any of the devices listed on Attachment I. Business Reply Forms were sent to the domestic and foreign consignees on May 3, 2013. The domestic notices were mailed by USP Priority Mail pouches. The recall is being conducted to the end user level. We ask that you contact all of those organizations within your facility and any other facilities that you may have supplied or given these affected products to. It is imperative that all end users of these devices receive this notice and respond immediately. If you have questions, please call 1 315-624-3237 or fax to +1 315-624-3225.

Recalling firm

Firm: ConMed Corporation
Address: 525 French Road, Utica, New York 13502

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide) and the country of: Saudi Arabia.

Timeline

Recall initiated: 2013-05-03
Posted by FDA: 2013-05-13
Terminated: 2015-08-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117902. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.