Maquet Medical Systems USA FDA Recalls

36 recalls on file across devices, 1 of them Class I and 35 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

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Product	Reason	Class	Initiated
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.Class IIApr 15, 2024The firm identified that the measured patient leakage curren	The firm identified that the measured patient leakage current in some devices significantly exceeded expected	Class IIDevices	Apr 15, 2024
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machiClass IIJan 16, 2024The Emergency Priming Line, a component of the HLS Set, may	The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconfo	Class IIDevices	Jan 16, 2024
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-Class IIJan 16, 2024The Emergency Priming Line, a component of the HLS Set, may	The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconfo	Class IIDevices	Jan 16, 2024
BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal carClass IIJan 8, 2024Nonconformities at their seal could potentially compromise t	Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach o	Class IIDevices	Jan 8, 2024
BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal carClass IIJan 8, 2024Nonconformities at their seal could potentially compromise t	Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach o	Class IIDevices	Jan 8, 2024
Bubble Sensor (REF: 70105.5720)Class IIDec 28, 2023The Bubble Sensor optional accessory to the CARDIOHELP-i ext	The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorr	Class IIDevices	Dec 28, 2023
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through tClass IIINov 14, 2023CARDIOHELP-i System was not properly tested to measure leaka	CARDIOHELP-i System was not properly tested to measure leakage current	Class IIIDevices	Nov 14, 2023
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 anClass IINov 13, 2023Firm received complaints of breaks in the insulation, shield	Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable	Class IIDevices	Nov 13, 2023
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood throughClass IINov 6, 2023Certain factory settings for the device were incorrectly des	Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits fo	Class IIDevices	Nov 6, 2023
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (SliClass IIOct 12, 2023It was found that the fixation (weld) employed by the suppli	It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was ins	Class IIDevices	Oct 12, 2023
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carboClass IOct 10, 2023Product removal due to possible blocking or impairment of th	Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead	Class IDevices	Oct 10, 2023
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 3Class IIMay 18, 2023Product packaging may exhibit small pinholes which may not b	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the ste	Class IIDevices	May 18, 2023
QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000Class IIMay 18, 2023Product packaging may exhibit small pinholes which may not b	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the ste	Class IIDevices	May 18, 2023
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USAClass IIMay 18, 20231. An accessory may be improperly placed during packaging, c	1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's ster	Class IIDevices	May 18, 2023
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA Class IIMay 18, 20231. An accessory may be improperly placed during packaging, c	1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's ster	Class IIDevices	May 18, 2023
QUADROX-iR, used during cardiopulmonary bypass Model Item No. DescriptioClass IIMay 18, 2023Product packaging may exhibit small pinholes which may not b	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the ste	Class IIDevices	May 18, 2023
QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item NoClass IIMay 18, 2023Product packaging may exhibit small pinholes which may not b	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the ste	Class IIDevices	May 18, 2023
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No.Class IIMay 18, 2023Product packaging may exhibit small pinholes which may not b	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the ste	Class IIDevices	May 18, 2023
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-Class IIMay 18, 2023Product packaging may exhibit small pinholes which may not b	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the ste	Class IIDevices	May 18, 2023
BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859Class IIMay 18, 20231. An accessory may be improperly placed during packaging, c	1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory s steri	Class IIDevices	May 18, 2023
HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840Class IIMay 18, 20231. An accessory may be improperly placed during packaging, c	1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's steri	Class IIDevices	May 18, 2023
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOClass IIMay 18, 2023Product packaging may exhibit small pinholes which may not b	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the ste	Class IIDevices	May 18, 2023
BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829Class IIMay 18, 20231. An accessory may be improperly placed during packaging, c	1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's ster	Class IIDevices	May 18, 2023
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Class IIMay 18, 2023Product packaging may exhibit small pinholes which may not b	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the ste	Class IIDevices	May 18, 2023
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HClass IIMay 18, 20231. An accessory may be improperly placed during packaging, c	1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's ster	Class IIDevices	May 18, 2023
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10Class IIMay 18, 20231. An accessory may be improperly placed during packaging, c	1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's ster	Class IIDevices	May 18, 2023
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA Class IIMay 18, 20231. An accessory may be improperly placed during packaging, c	1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's ster	Class IIDevices	May 18, 2023
BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905Class IIMay 18, 20231. An accessory may be improperly placed during packaging, c	1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's ster	Class IIDevices	May 18, 2023
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA Class IIMay 18, 20231. An accessory may be improperly placed during packaging, c	1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's steri	Class IIDevices	May 18, 2023
BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product CodClass IIFeb 13, 2023Firm has initiated a removal of the product due to insuffici	Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a	Class IIDevices	Feb 13, 2023
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratClass IIJul 22, 2022The firm has expanded the recall for the HLS Set Advanced re	The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrie	Class IIDevices	Jul 22, 2022
BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratClass IIJul 22, 2022The firm has expanded the recall for the HLS Set Advanced re	The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrie	Class IIDevices	Jul 22, 2022
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratClass IIJul 22, 2022The firm has expanded the recall for the HLS Set Advanced re	The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrie	Class IIDevices	Jul 22, 2022
BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratClass IIJul 22, 2022The firm has expanded the recall for the HLS Set Advanced re	The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrie	Class IIDevices	Jul 22, 2022
Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal systClass IIFeb 18, 2022Potential for a loose cylindrical pin on the Transport Guard	Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mec	Class IIDevices	Feb 18, 2022
Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blClass IIJul 14, 2021There is the potential for contaminated water to enter parts	There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a po	Class IIDevices	Jul 14, 2021