Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported April 14, 2021
Medtronic HVAD Alarm Adapter, Product Number: 1450
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD C…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Heartware, Inc. recalled Medtronic HVAD Alarm Adapter, Product Number: 1450 - a critical-severity action.
Medtronic HVAD Alarm Adapter, Product Number: 1450 was recalled by Heartware, Inc. in April 14, 2021. Reason: There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Ala…. Check the official notice for the remedy. Verify recall #Z-1338-2021 with the FDA Devices before acting.
The recall
Heartware, Inc. issued this critical-severity FDA Devices recall-There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Ala….
- Critical
- severity level
- 418 units
- affected scope
- Class I
- classification
- April 14, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1338-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1338-2021) was formally reported on April 14, 2021, with the manufacturer initiating the action on February 26, 2021. 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 418 units (315 US).
The documented reason for this recall is: There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cable… Distribution data in the federal record shows the product reached: Worldwide. 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
418 units (315 US)
Related Recalls
6
3 from same agency
Product description
Medtronic HVAD Alarm Adapter, Product Number: 1450
Reason for recall
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1338-2021 |
| Date reported | April 14, 2021 |
| Date initiated | February 26, 2021 |
| Recalling firm | Heartware, Inc. |
| Firm location | Miami Lakes, FL |
| Affected scope | 418 units (315 US) |
| Distribution | Worldwide |
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-1338-2021) 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? ▼
Medtronic HVAD Alarm Adapter, Product Number: 1450. Recalled by Heartware, Inc.. Units affected: 418 units (315 US).
Why was this product recalled? ▼
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 14, 2021. Severity: Critical. Recall number: Z-1338-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1338-2021) 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 April 14, 2021. 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.