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DTS-3000
DAESUNG MAREF CO.,LTD. · Model DTSW310-DT · UDI-DI 08809802646988
KCY
Prescription
10
510(k) clearances
1,989
Adverse events (1 deaths)
47
Recalls
108
Facilities
Description
Main Device 1ea, Red Main Hose 1ea, Blue Main Hose 1ea, Gray Main Hose 2ea, IOP Sensor 1ea [One Set Box]
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-09 | Zimmer Surgical Inc | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insigni |
| 2026-06-09 | Zimmer Surgical Inc | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insigni |
| 2026-03-12 | Stryker Sustainability Solutions | Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure. |
| 2025-12-24 | Zimmer Surgical Inc | Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternat |
| 2025-12-24 | Zimmer Surgical Inc | Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternat |
| 2025-07-02 | Stryker Corporation | Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Ot |
| 2024-05-31 | Stryker Sustainability Solutions | Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder. |
| 2023-03-01 | Stryker Corporation | Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, |
| 2023-03-01 | Stryker Sustainability Solutions | Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or uns |
| 2023-03-01 | Stryker Corporation | Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, |
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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.