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Aventus Thrombectomy System - Clot Management System

Inquis Medical, Inc. · Model IM-0002 · UDI-DI 00860009303416

CAC Prescription

510(k) clearances

3,172

Adverse events (83 deaths)

Recalls

Facilities

Description

The Aventus Clot Management System is connected to the aspiration syringe and is used to filter and return blood to the patient as desired. The clot canister contains a coarse pre-filter to separate blood from clot and is designed to be compatible with off-the-shelf blood transfusion filters.

Recalls

Date	Firm	Reason
2023-12-13	Maquet Cardiovascular, LLC	Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectio
2023-12-13	Maquet Cardiovascular, LLC	Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectio
2023-11-01	Atrium Medical Corporation	A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadverte
2023-09-18	Atrium Medical Corporation	Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube
2023-09-18	Atrium Medical Corporation	Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube
2023-09-18	Atrium Medical Corporation	Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube
2023-09-05	Atrium Medical Corporation	Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation
2019-10-21	Haemonetics Corporation	Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl cor
2019-10-21	Haemonetics Corporation	Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl cor
2019-10-21	Haemonetics Corporation	Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl cor

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.