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MyoSleeve
ELASTIMED LTD · Model 1.0 · UDI-DI 07290020483003
JOW
Prescription
1
510(k) clearances
1,705
Adverse events (19 deaths)
32
Recalls
138
Facilities
Description
MyoSleeve Half leg, Small, Right, Short
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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Get your free API keyRead the docsData 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.