Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported May 3, 2017
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up commun…
Heartware recalled HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: … - a critical-severity action.
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: … was recalled by Heartware in May 3, 2017. Reason: In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump …. Check the official notice for the remedy. Verify recall #Z-1832-2017 with the FDA Devices before acting.
The recall
Heartware issued this critical-severity FDA Devices recall-In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump ….
- Critical
- severity level
- 9 units
- affected scope
- Class I
- classification
- May 3, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1832-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1832-2017) was formally reported on May 3, 2017, with the manufacturer initiating the action on March 10, 2017. It is classified under Critical severity (Class I), with a current status of Ongoing. Heartware is listed as the recalling firm, operating out of Miami Lakes, FL. Federal records list the affected scope as 9 units.
The documented reason for this recall is: In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informi… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany.. 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
9 units
Related Recalls
6
3 from same agency
Product description
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
Reason for recall
In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1832-2017 |
| Date reported | May 3, 2017 |
| Date initiated | March 10, 2017 |
| Recalling firm | Heartware |
| Firm location | Miami Lakes, FL |
| Affected scope | 9 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany. |
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-1832-2017) 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) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).. Recalled by Heartware. Units affected: 9 units.
Why was this product recalled? ▼
In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 3, 2017. Severity: Critical. Recall number: Z-1832-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1832-2017) 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 May 3, 2017. 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.