The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1317-2013·Announced 2013-05-22

ConMed Recalls PadPro Adult Radiotransparent Multifunction Electrodes Due to Connector Damage

ConMed is recalling PadPro Adult Radiotransparent Multifunction Electrodes because damaged connector tooling may pinch lead wire filaments, potentially preventing the device from delivering appropriate energy or causing injury.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a defect could render it incapable of delivering appropriate energy or shock, posing a risk of harm to patients or users. No injuries or illnesses have been reported, and the agency classification is Class II, which aligns with a High severity rating for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ConMed Corporation is recalling PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. These devices are intended for use in external pacing, defibrillation, and monitoring applications. The recall involves 49,010 units distributed domestically in the United States and 600 units distributed in Saudi Arabia.

The recall was initiated after ConMed was notified by its contract manufacturer that a wire/connector supplier reported damage to the connector tooling. This damage could pinch or compress the lead wire filaments. Such damage may render the device incapable of delivering the appropriate energy or shock to a patient and could potentially cause injury to the user or patient.

The affected lots include Y092012-21, Y102612-12, Y110912-20, Y112912-10, Y121312-19, Y011013-13, Y012513-02, Y020713-05, Y021413-03, and Y030113-04. Manufacture dates for these lots range from October 10, 2012, to March 23, 2013. Healthcare facilities and users should stop using the affected devices and contact ConMed Corporation for further instructions.

The recalled product

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…
Manufacturer
ConMed Corporation
Category
Medical Device — Cardiac Monitoring and Pacing
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

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