Maquet Medical Systems USA recalls
Every recall we track for Maquet Medical Systems USA — 36 in all, from 2021–2024 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Maquet Medical Systems USA dropped to zero in 2025 (0, down from 5 in 2024). 3% rated “stop using now”.
All FDA recall records for Maquet Medical Systems USA since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 0 | 0 | 1 |
| 2022 | 0 | 4 | 1 | 0 | 5 |
| 2023 | 0 | 10 | 13 | 2 | 25 |
| 2024 | 1 | 4 | 0 | 0 | 5 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Maquet Medical Systems USA product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Maquet Medical Systems USA recalls
15 shown- Use cautionMedical device
Maquet Medical Systems USA recalls CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Maquet recalls Cardiohelp-i blood oxygenation systems with potential patient leakage current exceeding safe levels. Affected units have specific serial numbers and part numbers listed in the recall notice.
MaquetApr 15, 2024 - Stop using nowMedical device
Maquet Medical Systems USA recalls BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung
Maquet recalls BEQ-HLS 7050 USA HLS Set Advanced 7.0 with possible compromised sterile barrier causing infection risks. Affected units include specific product codes and lots. Stop using immediately to avoid infection.
MaquetJan 16, 2024 - Use cautionMedical device
Maquet Medical Systems USA recalls BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal
Maquet Medical Systems recalls BO-RF-32-USA RotaFlow pumps with SOFTLINE coating due to potential sterile barrier compromise. Breach could cause infection or sepsis in patients during extracorporeal circulation.
Maquet Medical SystemsJan 8, 2024 - Lower riskMedical device
Maquet Medical Systems USA recalls Bubble Sensor (REF: 70105.5720)
Maquet recalls Bubble Sensor (REF: 70105.5720) with incorrect UDI Device Identifier on labels. Affected units have specific serial numbers and correct identifier 04037691816432.
MaquetDec 28, 2023 - UnratedMedical device
Maquet Medical Systems USA recalls CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through
Maquet recalls Cardiohelp-i heart lung support systems due to untested leakage current. This device pumps blood during surgery; affected units have specific serial numbers up to 90415172.
MaquetNov 14, 2023 - Use cautionMedical device
Maquet Medical Systems USA recalls Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780
Maquet recalls Venous probe connection cables (REF 701069333, 701048804) used with Cardiohelp-i System. Broken insulation may cause blood flow errors, risking patient safety during extracorporeal support.
Maquet Medical SystemsNov 13, 2023 - UnratedMedical device
Maquet Medical Systems USA recalls CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood
Maquet recalls Cardiohelp-i heart lung support systems with incorrect factory settings that could risk improper blood oxygenation. Affected units have specific part numbers and serial numbers up to 90415177.
Maquet Medical SystemsNov 6, 2023 - Use cautionMedical device
Maquet Medical Systems USA recalls Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550
Maquet recalls Cardiohelp-i blood oxygenation systems with part numbers 701072780 and 701068550 due to risk of nut bolt breaking off during use, potentially causing injury.
MaquetOct 12, 2023 - Use cautionMedical device
Maquet Medical Systems USA recalls CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and
Maquet recalls Cardiohelp Emergency Drive models with part numbers 701048002 and 701076205 due to possible blood flow blockage causing patient hypoxia and ischemia.
Maquet Medical SystemsOct 10, 2023 - Use cautionMedical device
Maquet Medical Systems USA recalls QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA
Maquet recalls QUADROX-i Pediatric Oxygenators due to packaging defects that could compromise sterile barriers, risking infection. Affected units include specific model numbers and lots.
Maquet Medical SystemsMay 18, 2023 - Use cautionMedical device
Maquet Medical Systems USA recalls QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA
Maquet recalls QUADROX -i neonatal oxygenators with packaging pinholes that could allow contamination. Affected units may cause infection or sepsis if sterile barrier is compromised.
Maquet Medical SystemsMay 18, 2023 - Use cautionMedical device
Maquet Medical Systems USA recalls BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code
Maquet recalls BEQ-HLS 5050 and 7050 sets due to non-sterile packaging. Exposure may cause infection or sepsis. Affected units include specific product codes and batches.
Maquet Medical SystemsFeb 13, 2023 - Lower riskMedical device
Maquet Medical Systems USA recalls BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory
Maquet Medical Systems recalls HLS Set Advanced 5.0 (Part No. 70105.2797) due to potential sterility barrier breach. This could compromise product sterility for extracorporeal respiratory support.
Maquet Medical SystemsJul 22, 2022 - Use cautionMedical device
Maquet Medical Systems USA recalls Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system
Maquet recalls Cardiohelp-i Transport Guard (serials 90413945-90414319) due to potential loose pin causing jamming or disassembly, delaying critical medical support.
Maquet Medical SystemsFeb 18, 2022 - Use cautionMedical device
Maquet Medical Systems USA recalls Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for
Maquet recalls HCU 30 Heater Cooler Units due to potential bacterial contamination, including Mycobacteria. Affected units have specific model numbers and serial numbers. Consumers should contact Maquet for details.
Maquet Medical SystemsJul 14, 2021
Maquet Medical Systems USA recall questions
How many recalls has Maquet Medical Systems USA had?
36 recalls from Maquet Medical Systems USA are on record with U.S. safety agencies, from 2021–2024.
What is the most recent Maquet Medical Systems USA recall?
Maquet Medical Systems USA recalls CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system., dated Apr 15, 2024. Every Maquet Medical Systems USA recall is listed on this page, newest first.
What should I do if I have a recalled Maquet Medical Systems USA product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Maquet Medical Systems USA recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.