Recall Z-1768-2020— 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: Rhythm Xience Guider Catheter Introducer with Lancer Intergrated 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
Rhythm Xience Guider Catheter Introducer with Lancer Intergrated 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.