Boston Scientific recalls 21 ENDOTAK RELIANCE defibrillation leads due to test errors
Boston Scientific is recalling 21 ENDOTAK RELIANCE defibrillation leads because manufacturing test records showed suspected data recording errors. No injuries have been reported.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source explicitly states that no injuries have been reported. The hazard is a suspected data recording error rather than a confirmed physical defect causing harm, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Boston Scientific CRM Corp is recalling 21 units of the ENDOTAK RELIANCE SG transvenous defibrillation lead, Models 0180 and 0292. These sterile, ethylene oxide-sterilized leads are used in automatic implantable cardioverter defibrillator (AICD) systems to provide pacing, rate-sensing, and defibrillation shocks.
The recall was initiated after a review of manufacturing test records revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. The affected units were distributed worldwide, including in the United States (Ohio and Minnesota) and France.
There are no reported injuries associated with these devices. Patients with these specific leads implanted should contact their healthcare provider for further evaluation and instructions.
The recalled product
- Product
- Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter…
- Manufacturer
- Boston Scientific CRM Corp
- Affected units
- 21
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)
- Model 0180 s/n 310735 & 310892. Model 0292 s/n 130450
- & 309339.
Distribution
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