FDAFDA · Food and drugs·Recall number Z-0938-2017
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Published January 11, 2017 · Recall initiated: November 30, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Worldwide Distribution - US Distribution to the states of : IA and NY., and to the countries of : United Kingdom, Netherlands, Italy, Germany and Belgium.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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