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Acutus Medical Recalls
4 recalls on record · April 29, 2020 to April 29, 2020 · Medical Devices
April 29, 2020Medical DevicesFDA
Acutus Medical Inc recalls Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, S
Hazard: It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
April 29, 2020Medical DevicesFDA
Acutus Medical Inc recalls Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, R
Hazard: It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
April 29, 2020Medical DevicesFDA
Acutus Medical Inc recalls Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 S
Hazard: It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
April 29, 2020Medical DevicesFDA
Acutus Medical Inc recalls Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxO
Hazard: It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.