Drug & Device Safety Atlas

FDA recall record · openFDA

Maquet Medical Systems USA

30 FDA recalls on record (2023–2024) — 30 device. 30 still ongoing.

1
Class I (most serious)
28
Class II
1
Class III
30
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barri 8
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 7
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at 2
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile 2

Recalls

CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbo Class I 2023-10-10 CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. Class II 2024-04-15 BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machi Class II 2024-01-16 Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart- Class II 2024-01-16 BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal car Class II 2024-01-08 BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal car Class II 2024-01-08 QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. Class II 2023-05-18 QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ- Class II 2023-05-18 Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Sli Class II 2023-10-12 QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA Class II 2023-05-18 BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Cod Class II 2023-02-13 BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905 Class II 2023-05-18 QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA Class II 2023-05-18 QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO Class II 2023-05-18 QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000 Class II 2023-05-18 Bubble Sensor (REF: 70105.5720) Class II 2023-12-28 QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No Class II 2023-05-18 CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through Class II 2023-11-06 BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859 Class II 2023-05-18 QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-H Class II 2023-05-18 Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 an Class II 2023-11-13 QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA Class II 2023-05-18 QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 3 Class II 2023-05-18 QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA Class II 2023-05-18 Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10 Class II 2023-05-18 Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Class II 2023-05-18 QUADROX-iR, used during cardiopulmonary bypass Model Item No. Descriptio Class II 2023-05-18 BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829 Class II 2023-05-18 HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840 Class II 2023-05-18 CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through t Class III 2023-11-14

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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