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venowave

Saringer Life Science Technologies Inc · Model vw5-6m · UDI-DI 00683601000053

JOW Prescription

510(k) clearances

1,711

Adverse events (19 deaths)

Recalls

139

Facilities

Description

The VW5 is a peristaltic wave pump driven by a small DC gearmotor and powered by a single AA battery.The puhttps://gudid.fda.gov/gudid/resources/images/icons/icon_info_small.pngmp assembly is intended for application to the calf of the leg, though in principal, it may be used on other parts of the body. The calf, in particular, is the site where clots can form in the bloodstream, and hence the application of a pump to this site can prevent the formation of these clots by preventing pooling and stagnation of blood in this area. It also prevents accumulation of blood or lymphatic fluids that cause swelling and pain (Post Thrombotic syndrome, PTS) by pumping this area out.

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)

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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.