Device recall: Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits…
Class I FDA enforcement event 80056. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary power source and/or unexpected audible tones (beeping). The interruption typically lasts 1-2 seconds, due to oxidation between power source connector and socket.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Heartware started this device recall on 2 May 2018. The firm address in the FDA record is in Miami Lakes, FL. FDA put the recall in Class I. FDA event 80056 has 1 product record. The first FDA enforcement report date is 6 Jun 2018. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution including US Nationwide, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France,…
Recalling firm
Heartware, Miami Lakes, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1903-2018 | Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack, Product number: 1650DE Indication for Use for OUS… | 175878 devices | Class I | Ongoing | 6 Jun 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class I
- 4%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 Mar 2017 | HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline | Device | Class I | 1 |
| 3 Feb 2017 | HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardia | Device | Class I | 1 |
Official channels
- FDA enforcement report Z-1903-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 80056. https://recallregister.com/fda/i/80056/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution including US Nationwide, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France,…
- What quantity of product is in FDA event 80056?
- The FDA record gives this quantity:
175878 devices
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 4% of the 1,074 device events that started in 2018 are in Class I.