Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported June 29, 2022
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prev…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Inc recalled HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device … - a critical-severity action.
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device … was recalled by Medtronic Inc in June 29, 2022. Reason: Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resul…. Check the official notice for the remedy. Verify recall #Z-1266-2022 with the FDA Devices before acting.
The recall
Medtronic Inc issued this critical-severity FDA Devices recall-Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resul….
- Critical
- severity level
- Class I
- classification
- June 29, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1266-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1266-2022) was formally reported on June 29, 2022, with the manufacturer initiating the action on May 5, 2022. It is classified under Critical severity (Class I), with a current status of Ongoing. Medtronic Inc is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 429 batteries.
The documented reason for this recall is: Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete … Distribution data in the federal record shows the product reached: Worldwide Distribution. US nationwide, Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, North Macedonia, Norway, Poland, Spain, Switzerland, and the United Kingdom.. 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
429 batteries
Related Recalls
6
3 from same agency
Product description
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Reason for recall
Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly recharging.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1266-2022 |
| Date reported | June 29, 2022 |
| Date initiated | May 5, 2022 |
| Recalling firm | Medtronic Inc |
| Firm location | Minneapolis, MN |
| Affected scope | 429 batteries |
| Distribution | Worldwide Distribution. US nationwide, Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, North Macedonia, Norway, Poland, Spain, Switzerland, and the United Kingdom. |
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-1266-2022) 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 Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.. Recalled by Medtronic Inc. Units affected: 429 batteries.
Why was this product recalled? ▼
Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly recharging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 29, 2022. Severity: Critical. Recall number: Z-1266-2022.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution. US nationwide, Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, North Macedonia, Norway, Poland, Spain, Switzerland, and the United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1266-2022) 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.
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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 June 29, 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.