Every recall we track for Maquet Medical Systems USA — 36 in all — plus the complaints and injury reports the public filed about them.
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.
Maquet Medical Systems USA recalls Model BEQ-HLS 5050 USA HLS Set Advanced 5.0 (Product Code 70106.9077) used with CARDIOHELP. The Emergency Priming Line may have a compromised sterile barrier, risking infection or sepsis. Affected units include specific lots.
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.
Maquet recalls BEQ-RF-32-USA RotaFlow pumps with BIOLINE coating (Product Code 701047554) due to potential sterile barrier compromise. Affected units risk infection or sepsis if used without proper sterility.
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 recalls Bubble Sensor (REF: 70105.5720) with incorrect UDI Device Identifier on labels. Affected units have specific serial numbers and correct identifier 04037691816432.
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.
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 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 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.
Maquet recalls Cardiohelp Emergency Drive models with part numbers 701048002 and 701076205 due to possible blood flow blockage causing patient hypoxia and ischemia.
Maquet recalls HMOD 70000-USA/QUADROX-iD Adult Oxygenators due to packaging defects that could compromise sterility, risking infection during surgery. All units are affected.
Maquet Medical Systems recalls QUADROX-i Adult Oxygenators due to packaging defects that could expose non-sterile materials, risking infection during surgery. All units are affected.
Maquet recalls QUADROX-iR cardiopulmonary bypass devices due to potential pinholes in packaging that could compromise sterility, risking infection and inflammation.
Maquet recalls Venous Hardshell Cardiotomy Reservoirs with potential packaging pinholes that could allow contamination. Affected units may risk infection during surgery. Contact for return instructions.
Maquet recalls Venous Hardshell Cardiotomy Reservoirs with packaging defects that could cause infection. Affected units have specific model numbers and serials. Stop using if packaging shows damage.
Maquet recalls QUADROX-i Small Adult Oxygenators due to packaging defects that could expose non-sterile materials, risking infection during surgery. Affected units have specific model numbers and serials.
Maquet recalls QUADROX-i Pediatric Oxygenators with packaging pinholes that may allow non-sterile exposure, risking infection. Affected units include specific model numbers and lots sold globally.
Maquet recalls QUADROX-i Adult Oxygenators due to packaging defects that could cause infection or inflammation if sterile barrier is compromised.
Maquet recalls QUADROX-iR cardiopulmonary bypass devices due to packaging defects that could compromise sterility, risking infection and inflammation. Affected units have specific model numbers and item numbers.
Maquet recalls Quadrox-iD oxygenators due to packaging defects that could expose non-sterile materials, risking infection during heart surgery. All units are affected.
Maquet recalls QUADROX-iD Pediatric Oxygenators due to packaging pinholes that could allow non-sterile exposure, risking infection and sepsis. Affected units include specific model numbers and lots.
Maquet recalls QUADROX-iD Adult Oxygenators with potential packaging pinholes that could allow contamination, risking infection during surgery. Affected units have specific model numbers and were sold in the U.S. between 2019-2020.
Maquet recalls QUADROX-i Adult Oxygenators due to potential packaging pinholes that could allow non-sterile exposure, risking infection during surgery. Affected units have specific model numbers and serial codes.
Maquet recalls QUADROX -i neonatal oxygenators with packaging defects that could cause infection. Affected units have specific model numbers and serials; contact for repair or replacement.
Maquet recalls QUADROX-i Small Oxygenators due to packaging defects that could expose non-sterile materials, risking infection during surgery. All units are affected.
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 recalls QUADROX-i Small Adult Oxygenators with potential packaging pinholes that could allow non-sterile exposure, risking infection. Affected units include specific model numbers and lots.
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 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 recalls BEQ-HLS 5050 USA and HLS Set Advanced 5.0 sets due to potential sterility barrier breach. This could compromise product sterility, risking infection during extracorporeal respiratory support. Affected units include specific lot numbers.
Maquet recalls BEQ-HLS 7050 USA and HLS Set Advanced 7.0 sets due to potential sterility barrier breaches that could compromise product sterility. Affected units include specific lot numbers from November 2020.
Maquet recalls BEQ-HLS 7050 USA and HLS Set Advanced 7.0 sets due to potential sterility barrier breaches that could compromise product sterility. Affected units include specific part numbers and lots.
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 recalls Cardiohelp-i Transport Guard (serials 90413945-90414319) due to potential loose pin causing jamming or disassembly, delaying critical medical support.
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.
