Boston Scientific Corporation: Medical Device Recall in 2018 - (Recall #: Z-0474-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.

Product Classification:

Class II

Date Initiated: November 1, 2018

Date Posted: November 28, 2018

Recall Number: Z-0474-2019

Event ID: 81471

Reason for Recall:

Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.

Status: Terminated

Product Quantity: 12,900

Code Information:

SQ-RX Pulse Generator Model 1010

Distribution Pattern:

US Nationwide Distribution: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.

Voluntary or Mandated:

Voluntary: Firm initiated