Device recall: Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is…
Class I FDA enforcement event 67815. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.
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 21 Mar 2014. The firm address in the FDA record is in Mahwah, NJ. FDA put the recall in Class I. FDA event 67815 has 1 product record. The first FDA enforcement report date is 28 May 2014. The record gives the status Terminated, with the termination date 20 Mar 2018.
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 - USA (nationwide) and approximately 104 countries.
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
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1523-2014 | Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures. | 11,881 units (US 5183 and OUS 6698) | Class I | Terminated | 28 May 2014 |
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 2014
- 1,176
- Share of these events in Class I
- 5%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 9
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Sep 2018 | Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 | Device | Class I | 2 |
| 3 May 2018 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-080 | Device | Class I | 1 |
| 17 Jul 2017 | CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing | Device | Class I | 3 |
| 16 Jun 2017 | CS 100i Intra-Aortic Balloon Pump | Device | Class I | 3 |
| 23 Dec 2016 | CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part | Device | Class II | 1 |
| 16 Dec 2015 | Cardiosave Hybrid and rescue IABP | Device | Class II | 1 |
| 30 Jan 2015 | Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) | Device | Class II | 1 |
| 16 Dec 2014 | CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION | Device | Class II | 1 |
Maquet Datascope Corp - Cardiac Assist Division: all 9 events
Official channels
- FDA enforcement report Z-1523-2014The 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 67815. https://recallregister.com/fda/i/67815/. 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 - USA (nationwide) and approximately 104 countries.
- What quantity of product is in FDA event 67815?
- The FDA record gives this quantity:
11,881 units (US 5183 and OUS 6698)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 5% of the 1,176 device events that started in 2014 are in Class I.