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APA™ Handle

VENNER MEDICAL (SINGAPORE) PTE. LTD. · Model 701006 · UDI-DI 08885009190080

CCW

510(k) clearances

7,361

Adverse events (68 deaths)

Recalls

318

Facilities

Description

The APA™ Video Laryngoscope is a multi-functional device designed to assist direct and indirect laryngoscopy in routine and difficult airway intubations. It may be used to facilitate endotracheal intubation as part of general anaesthesia or CPR (cardiopulmonary resuscitation) during cardiac arrest. The video laryngoscope is reusable, DEHP-free and latex-free. It is fully detachable into three components: APA™ Video Viewer, APA™ Handle and APA™ MAC or MIL Camera Module. When used as a standard laryngoscope, the appropriate Camera Module is attached to the Handle to obtain a view of the laryngeal inlet during endotracheal intubation. When used as a video laryngoscope, the Video Viewer is attached to the Handle and Camera Module to provide improved visualisation during laryngoscopy and endotracheal intubation.

Recalls

Date	Firm	Reason
2025-07-11	Flexicare Medical (Dongguan) Ltd.	Laryngoscope handles may not illuminate as intended.
2025-07-11	Flexicare Medical (Dongguan) Ltd.	Laryngoscope handles may not illuminate as intended.
2025-07-11	Flexicare Medical (Dongguan) Ltd.	Laryngoscope handles may not illuminate as intended.
2025-07-11	Flexicare Medical (Dongguan) Ltd.	Laryngoscope handles may not illuminate as intended.
2025-07-11	Flexicare Medical (Dongguan) Ltd.	Laryngoscope handles may not illuminate as intended.
2025-07-11	Flexicare Medical (Dongguan) Ltd.	Laryngoscope handles may not illuminate as intended.
2025-06-17	Intersurgical Inc	Potential for faulty devices as a result of depleted batteries.
2024-07-09	Covidien	IFU update to address device's battery handling information.
2024-07-09	Covidien	Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
2024-07-09	Covidien	Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.

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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.