medical MODERATE Updated 2017-01-11

Boston Scientific Corporation recalls Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.

See all recalls from Boston Scientific Corporation →

Recalled Product

Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

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.

Issued by

FDA

Affected States: IA, NY
Lot/Code Info: 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.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall