Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 28, 2021
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware
IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connect…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Heartware, Inc. recalled Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these dev… - a moderate-severity action.
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these dev… was recalled by Heartware, Inc. in April 28, 2021. Reason: IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being cor…. Check the official notice for the remedy. Verify recall #Z-1438-2021 with the FDA Devices before acting.
The recall
Heartware, Inc. issued this moderate-severity FDA Devices recall-IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being cor….
- Moderate
- severity level
- Class II
- classification
- April 28, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1438-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1438-2021) was formally reported on April 28, 2021, with the manufacturer initiating the action on February 26, 2021. It is classified under Moderate severity (Class II), 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 23123 (11292 US).
The documented reason for this recall is: IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" … Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution and the countries of Italy, Great Britain, Germany, Japan.. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
23123 (11292 US)
Related Recalls
6
3 from same agency
Product description
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD controller DC Adapter Model 1440. Heartware HVAD data cable - monitor Model 1575. Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack Model 1475. Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US.
Reason for recall
IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1438-2021 |
| Date reported | April 28, 2021 |
| Date initiated | February 26, 2021 |
| Recalling firm | Heartware, Inc. |
| Firm location | Miami Lakes, FL |
| Affected scope | 23123 (11292 US) |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Italy, Great Britain, Germany, Japan. |
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-1438-2021) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD controller DC Adapter Model 1440. Heartware HVAD data cable - monitor Model 1575. Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack Model 1475. Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US.. Recalled by Heartware, Inc.. Units affected: 23123 (11292 US).
Why was this product recalled? ▼
IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 28, 2021. Severity: Moderate. Recall number: Z-1438-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Italy, Great Britain, Germany, Japan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1438-2021) 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 28, 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.