Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported June 17, 2015
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
HeartWare Inc recalled HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1… - a critical-severity action.
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1… was recalled by HeartWare Inc in June 17, 2015. Reason: HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of…. Check the official notice for the remedy. Verify recall #Z-1698-2015 with the FDA Devices before acting.
The recall
HeartWare Inc issued this critical-severity FDA Devices recall-HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of….
- Critical
- severity level
- Class I
- classification
- June 17, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1698-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1698-2015) was formally reported on June 17, 2015, with the manufacturer initiating the action on April 29, 2015. 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 3,747 currently implanted worldwide.
The documented reason for this recall is: HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA and countries of Argentina, Australi…. 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
3,747 currently implanted worldwide
Related Recalls
6
3 from same agency
Product description
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
Reason for recall
HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1698-2015 |
| Date reported | June 17, 2015 |
| Date initiated | April 29, 2015 |
| Recalling firm | HeartWare Inc |
| Firm location | Miami Lakes, FL |
| Affected scope | 3,747 currently implanted worldwide |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA and countries of Argentina, Australia, Austria, Belgium,… |
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-1698-2015) 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). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.. Recalled by HeartWare Inc. Units affected: 3,747 currently implanted worldwide.
Why was this product recalled? ▼
HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2015. Severity: Critical. Recall number: Z-1698-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1698-2015) 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 17, 2015. 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.