Device recall: CS 100i Intra-Aortic Balloon Pump
Class I FDA enforcement event 77566. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
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
Maquet Datascope Corp - Cardiac Assist Division started this device recall on 16 Jun 2017. The firm address in the FDA record is in Mahwah, NJ. FDA put the recall in Class I. FDA event 77566 has 3 product records. The first FDA enforcement report date is 2 Aug 2017. The record gives the status Terminated, with the termination date 29 Nov 2019.
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 - (in over 100 countries) US (Nationwide)
Recalling firm
Maquet Datascope Corp - Cardiac Assist Division, Mahwah, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2736-2017 | CS 100i Intra-Aortic Balloon Pump | 12,319 units total | Class I | Terminated | 2 Aug 2017 |
| Z-2737-2017 | CS 100 Intra-Aortic Balloon Pump | 12,319 units total | Class I | Terminated | 2 Aug 2017 |
| Z-2738-2017 | CS 300 Intra-Aortic Balloon Pump | 12,319 units total | Class I | Terminated | 2 Aug 2017 |
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 2017
- 1,091
- Share of these events in Class I
- 3%
- Product records in this event
- 3Median of the firm: 1
- Events of the firm on the register
- 9
Other events of the firm
Maquet Datascope Corp - Cardiac Assist Division: all 9 events
Official channels
- FDA enforcement report Z-2736-2017The 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 77566. https://recallregister.com/fda/i/77566/. 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 - (in over 100 countries) US (Nationwide)
- What quantity of product is in FDA event 77566?
- The event has 3 product records. The first record gives this quantity:
12,319 units total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2017 have the same class?
- 3% of the 1,091 device events that started in 2017 are in Class I.