Device recall: HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Class II FDA enforcement event 93405. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Heartware, Inc. started this device recall on 31 Oct 2023. The firm address in the FDA record is in Miami Lakes, FL. FDA put the recall in Class II. FDA event 93405 has 9 product records. The first FDA enforcement report date is 13 Dec 2023. 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
Recalling firm
Heartware, Inc., 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
9 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0475-2024 | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 | 45 units | Class II | Ongoing | 13 Dec 2023 |
| Z-0476-2024 | STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 | 380 units | Class II | Ongoing | 13 Dec 2023 |
| Z-0477-2024 | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102 | 892 units | Class II | Ongoing | 13 Dec 2023 |
| Z-0478-2024 | PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 | 7438 units | Class II | Ongoing | 13 Dec 2023 |
| Z-0479-2024 | PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 | 10287 units | Class II | Ongoing | 13 Dec 2023 |
| Z-0480-2024 | 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN | 6 units | Class II | Ongoing | 13 Dec 2023 |
| Z-0481-2024 | PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP | 126 units | Class II | Ongoing | 13 Dec 2023 |
| Z-0482-2024 | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205 | 126 units | Class II | Ongoing | 13 Dec 2023 |
| Z-0483-2024 | PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU | 125 | Class II | Ongoing | 13 Dec 2023 |
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 II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 9Median of the firm: 1
- Events of the firm on the register
- 32
Other events of the firm
Official channels
- FDA enforcement report Z-0475-2024The 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 93405. https://recallregister.com/fda/ii/93405/. 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
- What quantity of product is in FDA event 93405?
- The event has 9 product records. The first record gives this quantity:
45 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.