CLASS II Device recall · Reported 29 Apr 2020 · FDA Enforcement Report
AcQGuide Mini Fixed-Curve Introducer recalled by Acutus Medical
Acutus Medical is recalling AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, distributed in Arizona, California, South Carolina. The recall was initiated on 25 Feb 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1769-2020
- FDA event ID
- 85197
- Recalling firm
- Acutus Medical, Carlsbad, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Feb 2020
- FDA classified
- 23 Apr 2020
- Reported
- 29 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Heart & Vascular Devices
Timeline
| 25 Feb 2020 | Recall initiated by company | |
| 23 Apr 2020 | Classified by FDA | +58 days |
| 29 Apr 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
Where it was distributed
US: CA,SC, AZ OUS: None
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Affected Lot Numbers/Expiration Date: 19101021 /October 2020 19103124 /October 2020 19121604 /December 2020
Where was it sold?
US: CA,SC, AZ OUS: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 85197This product is part of a recall event; the main page for the event is Rhythm Xience Guider Catheter Introducer recalled by Acutus Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Rhythm Xience Guider Catheter Introducer recalled by Acutus Medical | Acutus Medical | Particulate Matter | AZ, CA, SC | |
| CLASS II | Rhythm Xience Flextra Steerable Introducer recalled by Acutus Medical | Acutus Medical | Particulate Matter | AZ, CA, SC | |
| CLASS II | AcQGuide Flex Steerable Introducer recalled by Acutus Medical | Acutus Medical | Particulate Matter | AZ, CA, SC |
More recalls from Acutus Medical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | AcQGuide Flex Steerable Introducer recalled by Acutus Medical | Acutus Medical | Particulate Matter | AZ, CA, SC |
| Device | CLASS II | Rhythm Xience Flextra Steerable Introducer recalled by Acutus Medical | Acutus Medical | Particulate Matter | AZ, CA, SC |
| Device | CLASS II | Rhythm Xience Guider Catheter Introducer recalled by Acutus Medical | Acutus Medical | Particulate Matter | AZ, CA, SC |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |