Home › SUN SCIENTIFIC, INC. › AeroDVx ™

AeroDVx ™

SUN SCIENTIFIC, INC. · Model Small, Short, Unilateral · UDI-DI 00856525007570

JOW Prescription

510(k) clearances

1,711

Adverse events (19 deaths)

Recalls

138

Facilities

Description

The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pneumatic pump and hand pump to provide static and/or intermittent pneumatic compression for compression therapy or DVT Prophylaxis. The AeroDVx™ gradient compression sleeve is composed of a family of non-sterile single patient use medical devices. The AeroDVx ™ Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s leg. The AeroDVx ™ Gradient Compression Sleeve is available in four sizes and two different lengths (standard and short). The wrap is composed of two polyurethane laminates that are sealed together creating an internal bladder system. The bladder system contains circular and bar welds that were engineered with their spacing and location to provide gradient compression profile when worn and inflated. An inflation source is attached to the inflation valve on the sleeve. The insertion of the inflation source onto the check valve of pressure opens the leur valve so that the bladder can be inflated or deflated based on the direction of airflow. There will be two inflation sources provided: a portable, battery-operated intermittent pneumatic pump, the AeroDVx™ Pump, to provide intermittent pneumatic compression and a hand pump to provide static compression. The system is intended for hospital and outpatient use.

Recalls

Date	Firm	Reason
2025-05-13	Cardinal Health 200, LLC	Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
2025-05-13	Cardinal Health 200, LLC	Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
2025-05-13	Cardinal Health 200, LLC	Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
2023-04-14	Stryker Sustainability Solutions	Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
2021-07-09	Ortho8, Inc.	EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
2021-07-09	Ortho8, Inc.	CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
2019-04-08	Compass Health Brands (Corporate Office)	Product design change did not receive proper premarket clearance and lacks a 510 (k)
2019-04-08	Compass Health Brands (Corporate Office)	Product design change did not receive proper premarket clearance and lacks a 510 (k)
2019-04-08	Compass Health Brands (Corporate Office)	Product design change did not receive proper premarket clearance and lacks a 510 (k)
2019-04-08	Compass Health Brands (Corporate Office)	Product design change did not receive proper premarket clearance and lacks a 510 (k)

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.