Z-0726-2022 Class II Ongoing
FDA device recall Z-0726-2022 was initiated by Heartware, Inc. on Jan 27, 2022 and is designated Class II. Reason for recall: Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the… The recall status is ongoing. Affected quantity: 197,889 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 16, 2022
- Initiation Date
- Jan 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 197,889 units
Product Description
Reason for Recall
Distribution Pattern
Distribution throughout the United States. OUS distribution in Argentina, Armenia, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea (South), Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritius, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Poland, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.
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-0726-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026