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.
FDA Recall Z-0474-2019 · Posted None
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLWS
Date Initiated2018-11-01
Date Terminated2019-11-04
Product Quantity12,900
Reason for Recall
Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
Firm Action
The firm, Boston Scientific, sent an "Important Medical Device
Information" letter to customers on November 5, 2018 by hand, email via our sales representatives or Federal Express or Courier. The letter described the product, problem and actions to be taken. We will reconcile that 100% of the identified customers /customer representatives signed for the letter, or the letter has been confirmed to be delivered. Boston Scientific will post the product advisory letter on our website, within the Product Performance Resource Center located @ www.bostonscientific.com/en-US/pprc/product-advisories.html. The customers were instructed to do the following:
Your doctor has been notified to look for this possible change, so please go to all scheduled defibrillator checks and clinic visits. As always, if you or your family hear beeping from your device, please contact your heart clinic as soon as possible. Your doctor can confirm your ability to hear and recognize this sound during an appointment.
If you have additional questions regarding this information or would like to report a clinical event, please contact your Boston Scientific representative or
Technical Services, or the Recall Contact at 651-582-3494 or email: [email protected].
Root Cause
Device Design
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.