Z-0474-2019Class II

The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)...

Name: Z-0474-2019 The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)...
Creator: Boston Scientific Corporation
Published: 2018-11-01
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2018-11-01 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide... on 2018-11-01. FDA classified it as Class II and gives the reason as "Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0474-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-01
Posted: 2018-11-16
Terminated: 2019-11-04
Recalling firm: Boston Scientific Corporation
Product: 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 code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
Root cause tag: design
FDA root cause: Device Design
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].
Quantity in commerce: 12,900
Distribution: 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.
Product codes and lots: SQ-RX Pulse Generator Model 1010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0474-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0474-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-16

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)