Home › Therma Bright Inc › Venowave VW5

Venowave VW5

Therma Bright Inc · Model VW5-6 · UDI-DI 00627843553601

JOW Prescription

510(k) clearances

1,711

Adverse events (19 deaths)

Recalls

138

Facilities

Description

The Venowave VW5 series comprises compact, battery-operated non-pneumatic, non-sequential, peristaltic wave compression pumps designed to generate wave-form motion. When securely fastened below the knee on the calf, these pumps create compression, leading to an increased upward volumetric displacement of venous and lymph fluid. The device is used for Management of the symptoms of post thrombolytic syndrome (PTS), Prevention of deep vein thrombosis (DVT), Prevention of primary thrombosis, Treatment of lymphedema, Diminishing post-operative pain and swelling, Treatment of leg swelling due to vascular insufficiency, Treatment of varicose veins Treatment of chronic venous insufficiency.

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.