Device recall: Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
Class I FDA enforcement event 85397. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
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, Inc. started this device recall on 3 Apr 2020. The firm address in the FDA record is in Miami Lakes, FL. FDA put the recall in Class I. FDA event 85397 has 5 product records. The first FDA enforcement report date is 3 Jun 2020. 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
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
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2055-2020 | Heartware HVAD Pump Implant Kit, Product (REF) Number 1103 | 2614 units | Class I | Ongoing | 3 Jun 2020 |
| Z-2056-2020 | Heartware HVAD Pump Implant Kit, Product (REF) Number 1104 | 2225 Units | Class I | Ongoing | 3 Jun 2020 |
| Z-2057-2020 | Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP | 85 units | Class I | Ongoing | 3 Jun 2020 |
| Z-2058-2020 | Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125 | 20147 devices | Class I | Ongoing | 3 Jun 2020 |
| Z-2059-2020 | Heartware HVAD Pump Implant accessories, Product (REF) Number 1153 | 560 units | Class I | Ongoing | 3 Jun 2020 |
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 2020
- 916
- Share of these events in Class I
- 4%
- Product records in this event
- 5Median of the firm: 1
- Events of the firm on the register
- 32
Other events of the firm
Official channels
- FDA enforcement report Z-2055-2020The 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 85397. https://recallregister.com/fda/i/85397/. 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
- What quantity of product is in FDA event 85397?
- The event has 5 product records. The first record gives this quantity:
2614 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2020 have the same class?
- 4% of the 916 device events that started in 2020 are in Class I.