Z-0474-2019 Class II Terminated
FDA device recall Z-0474-2019 was initiated by Boston Scientific Corporation on Nov 1, 2018 and is designated Class II. Reason for recall: Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions. The recall status is terminated (terminated Nov 4, 2019). Affected quantity: 12,900.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 28, 2018
- Initiation Date
- Nov 1, 2018
- Termination Date
- Nov 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,900
Product Description
Reason for Recall
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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0474-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026