Recall Register

Maquet Medical Systems USA: FDA recalls

FDA enforcement reports name Maquet Medical Systems USA as the recalling firm in 20 events. The events have 41 product records. The recalls started from 2012 to 2024. 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

20 events, newest first.

FDA enforcement events of Maquet Medical Systems USA
InitiatedProduct (first record)TypeClassRecordsStatus
15 Apr 2024CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.DeviceClass II1Ongoing
16 Jan 2024Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.DeviceClass II2Ongoing
8 Jan 2024BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.DeviceClass II2Ongoing
28 Dec 2023Bubble Sensor (REF: 70105.5720)DeviceClass II1Ongoing
14 Nov 2023CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012DeviceClass III1Ongoing
13 Nov 2023Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802DeviceClass II1Ongoing
6 Nov 2023CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass Part Number: 701072780, (CARDIOHELP-I US); 701048012 (CARDIOHELP-I NON US)DeviceClass II1Ongoing
12 Oct 2023Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)DeviceClass II1Ongoing
10 Oct 2023CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.DeviceClass I1Ongoing
18 May 2023HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840DeviceClass II10Ongoing
18 May 2023QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388DeviceClass II8Ongoing
13 Feb 2023BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.DeviceClass II1Ongoing
22 Jul 2022BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.DeviceClass II4Ongoing
18 Feb 2022Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product Code/REF Number:…DeviceClass II1Ongoing
14 Jul 2021Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.DeviceClass II1Terminated
5 Oct 2016Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.DeviceClass II1Terminated
21 Aug 2014TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction with medical and non-medical devices.DeviceClass II1Terminated
16 Apr 2014Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.DeviceClass II1Terminated
12 Sep 2013MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.DeviceClass II1Terminated
13 Apr 2012Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before, during and after the surgical phase.…DeviceClass II1Terminated

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 Medical Systems USA: events for each product type
TypeEvents
Device20
Maquet Medical Systems USA: events in each class
ClassEvents
Class II18
Class I1
Class III1
Share of the events of the firm in Class I
5%
Share of all events on the register in Class I
18%
Events with the status Ongoing
14

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 Medical Systems USA, by the year that the recall started. The largest year is 2023, with 9 events.

Official channels

Cite this page

Recall Register. Maquet Medical Systems USA: FDA recalls. https://recallregister.com/firm/maquet-medical-systems-usa/. 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 Medical Systems USA have?
Class II: 18 events. Class I: 1 event. Class III: 1 event. 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 Medical Systems USA?
FDA event 94450, which the firm started on 15 Apr 2024. The first product in the record is: CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
How many FDA recalls of Maquet Medical Systems USA have the status Ongoing?
14 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.