Boston Scientific recall
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Why was Boston Scientific recalled?
Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the lead body.
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 7740 S/N 633464, 610662. Model 7741 S/N 657588, 563539, 628198, 636545, 641593, 656713, 656904. Model 7742 S/N 572200, 584869, 631202. Model 7732 S/N 488740. Model 7736 S/N 631322, 632188.
- Product
- Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 15 (2 US; 13 OUS)
- Distribution
- Worldwide Distribution - US Distribution to the states of : IA and NY., and to the countries of : United Kingdom, Netherlands, Italy, Germany and Belgium.
- Recall date
- January 11, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)