Acutus Medical recalls

Acutus Medical has 4 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 29 Apr 2020. The most frequent reason is particulate matter.

Total recalls4since 2020

Last 12 months0reported

Class I00% of total

Ongoing0latest 29 Apr 2020

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why acutus medical is recalled

Particulate Matter4100%

Product types

Heart & Vascular Devices4100%

By year

20204100%

All acutus medical recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
29 Apr 2020Device	CLASS II	AcQGuide Mini Fixed-Curve Introducer recalled by Acutus Medical	Acutus Medical	Particulate Matter	AZ, CA, SC
29 Apr 2020Device	CLASS II	AcQGuide Flex Steerable Introducer recalled by Acutus Medical	Acutus Medical	Particulate Matter	AZ, CA, SC
29 Apr 2020Device	CLASS II	Rhythm Xience Flextra Steerable Introducer recalled by Acutus Medical	Acutus Medical	Particulate Matter	AZ, CA, SC
29 Apr 2020Device	CLASS II	Rhythm Xience Guider Catheter Introducer recalled by Acutus Medical	Acutus Medical	Particulate Matter	AZ, CA, SC

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.