Replacement Lead Wires Recalled for Risk of Treatment Delivery Failure
EBI, LLC recalls 829 replacement lead wire assemblies (Part 1067724-2) distributed nationwide since May 1, 2023. Damaged wire sheaths may prevent therapeutic treatment signals from reaching electrodes, potentially delaying treatment.
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: FDA Class II classification for a medical device with potential treatment signal failure and delayed therapy. The hazard is theoretical with no illnesses or injuries reported, fitting the criterion for score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
EBI, LLC is recalling 20" replacement lead wires (Part Number 1067724-2, UDI-DI: 00812301020300) distributed nationwide since May 1, 2023. A total of 829 units, containing 2 lead wires per assembly, are affected.
The recalled lead wires have a defect in the sheath (black cable) component that can become damaged, exposing the internal wires. This damage may prevent the therapeutic treatment signal from being properly delivered to the electrodes, potentially resulting in delayed treatment.
The FDA has classified this as a Class II recall. Patients or healthcare providers who have these devices should contact EBI, LLC for replacement or further guidance.
The recalled product
- Product
- 20" Lead Wires, Replacement Part Number: 1067724-2
- Manufacturer
- EBI, LLC
- Hazard
- sheath-damage
- wire-exposure
- therapy-failure
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 (2)
- UDI-DI: 00812301020300 All devices distributed since May 1
- 2023
Distribution
Distributed nationwide across the United States.
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