Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported October 19, 2016
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
HeartWare, Inc recalled HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and Internation… - a critical-severity action.
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and Internation… was recalled by HeartWare, Inc in October 19, 2016. Reason: Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance r…. Check the official notice for the remedy. Verify recall #Z-0006-2017 with the FDA Devices before acting.
The recall
HeartWare, Inc issued this critical-severity FDA Devices recall-Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance r….
- Critical
- severity level
- Class I
- classification
- October 19, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0006-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0006-2017) was formally reported on October 19, 2016, with the manufacturer initiating the action on August 17, 2016. 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 344 pumps.
The documented reason for this recall is: Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults. Distribution data in the federal record shows the product reached: Worldwide Distribution - US, in the states of AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, and WI; and, the countries of Argentina, Belarus, Bosnia, Herzegovina, Br…. 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
344 pumps
Related Recalls
6
3 from same agency
Product description
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reason for recall
Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0006-2017 |
| Date reported | October 19, 2016 |
| Date initiated | August 17, 2016 |
| Recalling firm | HeartWare, Inc |
| Firm location | Miami Lakes, FL |
| Affected scope | 344 pumps |
| Distribution | Worldwide Distribution - US, in the states of AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, and WI; and, the countries of Argentina, Belarus, Bosnia, Herzegovina, Brazil, Canada, Chile,… |
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-0006-2017) 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 System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.. Recalled by HeartWare, Inc. Units affected: 344 pumps.
Why was this product recalled? ▼
Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 19, 2016. Severity: Critical. Recall number: Z-0006-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US, in the states of AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, and WI; and, the countries of Argentina, Belarus, Bosnia, Herzegovina, Brazil, Canada, Chile, Colombia, Hong Kong, India, Israel, Kazakhstan, Kuwait, Lebanon, Malaysia, New Zealand, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Taiwan, Turkey, and Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0006-2017) 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 October 19, 2016. 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.