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CuffTrek
SHANGHAI LONGMANN TECH CO.,LTD. · Model LG-1 · UDI-DI 36979264200004
BSK
Prescription
1
510(k) clearances
421
Adverse events (9 deaths)
4
Recalls
45
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-22 | Hamilton Medical AG | Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by |
| 2023-08-22 | Covidien | Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several |
| 2017-06-20 | Hamilton Medical, Inc. | Issue related to the performance of the motor in recalled product. During use, motor may cease to function. |
| 2013-08-27 | H & H Associates | Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective. |
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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.