Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Boston Scientific Recalled by Boston Scientific Corporation Due to Boston Scientific is conducting a recall on Boston...

Date: November 30, 2016
Company: Boston Scientific Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.

Affected Products

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

Quantity: 15 (2 US; 13 OUS)

Why Was This 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.

Where Was This Sold?

This product was distributed to 2 states: IA, NY

Affected (2 states)Not affected

About Boston Scientific Corporation

Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report