Home › Kal-Med, LLC › Pylant Monitor

Pylant Monitor

Kal-Med, LLC · Model IM-1000 · UDI-DI 00860010850909

BSK Prescription

510(k) clearances

423

Adverse events (9 deaths)

Recalls

Facilities

Description

Pylant Monitor - Disposable endotracheal tube cuff pressure monitor (15 units per box) - non AC-powered.

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.

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.