Boston Scientific ENDOTAK RELIANCE¿ SG recall
Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads…
Why was Boston Scientific ENDOTAK RELIANCE¿ SG recalled?
A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model 0180 s/n 310735 & 310892. Model 0292 s/n 130450, & 309339.
- Product
- Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads…
- Recalling firm
- Boston Scientific CRM Corp
- Quantity
- 21
- Distribution
- Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France
- Recall date
- August 13, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)