Recall Z-0938-2017— Boston Scientific Corporation
Class II · Terminated
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2016-11-30, terminated 2017-12-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.. Reason: 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..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-30
- Terminated
- 2017-12-13
- Firm location
- Saint Paul, MN, United States
Product description
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.