GE Healthcare Recalls Replacement ECG Leadwires Due to Defibrillation Risk
GE Healthcare is recalling 58,045 replacement ECG leadwires worldwide because they may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.
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 defect that could limit the success of a life-saving procedure (defibrillation), representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling 58,045 units of replacement ECG leadwires with snap ends (REF/Catalog Number 2106386-101). These reusable leadwire sets are used with GE equipment requiring rectangular 11-pin ECG trunk cables for ECG monitoring. The recall covers units distributed worldwide, including the United States (nationwide, including Puerto Rico) and numerous international markets.
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 delivery could potentially limit the success of defibrillating the patient's rhythm. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Healthcare facilities and consumers who have these specific leadwires should stop using them for defibrillation purposes and contact GE Healthcare for instructions on how to proceed. The product does not have lot or serial codes, and no GTIN/UDI is listed in the source information.
The recalled product
- Product
- Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets
- 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
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
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