Recall Register

Maquet Datascope Corp - Cardiac Assist Division: FDA recalls

FDA enforcement reports name Maquet Datascope Corp - Cardiac Assist Division as the recalling firm in 9 events. The events have 14 product records. The recalls started from 2014 to 2018. All the events are device recalls.

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 .

Enforcement events

9 events, newest first.

FDA enforcement events of Maquet Datascope Corp - Cardiac Assist Division
InitiatedProduct (first record)TypeClassRecordsStatus
20 Sep 2018Cardiosave Hybrid IABP, Part Number 0998-00-0800-53DeviceClass I2Ongoing
3 May 2018CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179DeviceClass I1Ongoing
17 Jul 2017CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through…DeviceClass I3Ongoing
16 Jun 2017CS 100i Intra-Aortic Balloon PumpDeviceClass I3Terminated
23 Dec 2016CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloonsDeviceClass II1Terminated
16 Dec 2015Cardiosave Hybrid and rescue IABPDeviceClass II1Terminated
30 Jan 2015Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)DeviceClass II1Terminated
16 Dec 2014CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic…DeviceClass II1Terminated
21 Mar 2014Datascope 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.DeviceClass I1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Maquet Datascope Corp - Cardiac Assist Division: events for each product type
TypeEvents
Device9
Maquet Datascope Corp - Cardiac Assist Division: events in each class
ClassEvents
Class I5
Class II4
Share of the events of the firm in Class I
56%
Share of all events on the register in Class I
18%
Events with the status Ongoing
3

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.

Events by year

FDA enforcement events of Maquet Datascope Corp - Cardiac Assist Division, by the year that the recall started. The largest year is 2014, with 2 events.

Official channels

Cite this page

Recall Register. Maquet Datascope Corp - Cardiac Assist Division: FDA recalls. https://recallregister.com/firm/maquet-datascope-corp-cardiac-assist-division/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
NJ

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Maquet Datascope Corp - Cardiac Assist Division have?
Class I: 5 events. Class II: 4 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Maquet Datascope Corp - Cardiac Assist Division?
FDA event 81055, which the firm started on 20 Sep 2018. The first product in the record is: Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
How many FDA recalls of Maquet Datascope Corp - Cardiac Assist Division have the status Ongoing?
3 events have the status Ongoing in the openFDA file. openFDA says 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.