Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported August 24, 2022
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to a…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Heartware, Inc. recalled HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE - a critical-severity action.
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE was recalled by Heartware, Inc. in August 24, 2022. Reason: Battery performance issues. Battery electrical faults render it unable to power the controller, unable to acc…. Check the official notice for the remedy. Verify recall #Z-1512-2022 with the FDA Devices before acting.
The recall
Heartware, Inc. issued this critical-severity FDA Devices recall-Battery performance issues. Battery electrical faults render it unable to power the controller, unable to acc….
- Critical
- severity level
- Class I
- classification
- August 24, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1512-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1512-2022) was formally reported on August 24, 2022, with the manufacturer initiating the action on June 28, 2022. It is classified under Critical severity (Class I), with a current status of Ongoing. Heartware, Inc. is listed as the recalling firm, operating out of Miami Lakes, FL. Federal records list the affected scope as 19616 batteries.
The documented reason for this recall is: Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while dischargin… Distribution data in the federal record shows the product reached: Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United Kingdom, Poland, Hungary, Czech Republic, Mauritius, France, South Africa, Greece, Netherlands, Swede…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
19616 batteries
Related Recalls
6
3 from same agency
Product description
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Reason for recall
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1512-2022 |
| Date reported | August 24, 2022 |
| Date initiated | June 28, 2022 |
| Recalling firm | Heartware, Inc. |
| Firm location | Miami Lakes, FL |
| Affected scope | 19616 batteries |
| Distribution | Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United Kingdom, Poland, Hungary, Czech Republic, Mauritius, France, South Africa, Greece, Netherlands, Sweden, Norway, Denmark, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1512-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE. Recalled by Heartware, Inc.. Units affected: 19616 batteries.
Why was this product recalled? ▼
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 24, 2022. Severity: Critical. Recall number: Z-1512-2022.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United Kingdom, Poland, Hungary, Czech Republic, Mauritius, France, South Africa, Greece, Netherlands, Sweden, Norway, Denmark, Estonia, Lebanon, Croatia, Spain, Austria, United Arab Emirates, Luxembourg, Canada, Korea, Republic Of, Israel, Qatar, India, Australia, New Zealand, Taiwan, Malaysia, Hong Kong, Singapore, Latvia, Saudi Arabia, Slovakia, North Macedonia, Finland, Turkey, Armenia, Colombia, Kazakhstan, Kuwait, Serbia, Bahrain, Egypt, Pakistan, and Ukraine..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1512-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 24, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.