Recall Z-1769-2020— Acutus Medical Inc
Class II · Terminated
Class II FDA medical device recall by Acutus Medical Inc, initiated 2020-02-25, terminated 2021-04-27. It names one FDA 510(k) clearance: K170373. Product: Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly. Reason: 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..
- Recalling firm
- Acutus Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-25
- Terminated
- 2021-04-27
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.