Acutus Medical AcQGuide Mini Fixed-Curve Introducer recall: Particulate Matter
Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
Why was Acutus Medical AcQGuide Mini Fixed-Curve Introducer 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Affected Lot Numbers/Expiration Date: 19101021 /October 2020 19103124 /October 2020 19121604 /December 2020
- Product
- Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
- Recalling firm
- Acutus Medical Inc
- Quantity
- 268 units
- Distribution
- US: CA,SC, AZ OUS: None
- Recall date
- April 29, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)