The Recall Desk
HighFDA (Devices)·Z-1877-2019·Announced 2019-07-03

GE Healthcare Recalls ECG Leadwires Due to Defibrillation Energy Reduction

GE Healthcare is recalling 58,045 replacement ECG leadwires because they may reduce energy reaching patients during defibrillation, potentially limiting treatment success.

What this means for you

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 that may reduce defibrillation energy, posing a risk of harm to patients. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).

Plain-English summary

GE Healthcare, LLC is recalling 58,045 units of replacement ECG leadwires with grabber ends. The affected products are reusable leadwire sets used with GE equipment requiring rectangular 11-pin ECG trunk cables. The recall covers 31,108 units in the United States and 26,937 units in other countries.

The recall was initiated because the ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation. This reduction in energy could potentially limit the success of defibrillating the patient's rhythm.

The products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in numerous other countries. The source text does not specify specific lot or serial codes for the affected units. Users of these leadwires should contact GE Healthcare for further instructions on how to proceed.

The recalled product

Product
Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA,
Manufacturer
GE Healthcare, LLC
Category
Medical Device — ECG Leadwires
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 (1)

  • product does not have lot or serial codes No GTIN/UDI

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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