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DTS-3000
DAESUNG MAREF CO.,LTD. · Model DTSW410-SS-2 · UDI-DI 08809802644236
KCY
Prescription
10
510(k) clearances
1,989
Adverse events (1 deaths)
47
Recalls
108
Facilities
Description
Device 1ea, SILICONE BLADDER CUFF(DTC-SA1843 1ea, DTC-SA2443 1ea, DTC-SA3043 1ea, DTC-SA3443 1ea, DTC-CD1855 1ea), Hose set (Red 1ea, Blue 1ea, Gray 2ea), IOP Sensor
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.