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Forsure

FORSURE MEDICAL PRODUCTS LLC · Model 11230035 · UDI-DI 00815123012102

CBI Prescription

510(k) clearances

1,577

Adverse events (12 deaths)

Recalls

Facilities

Description

A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. It is typically made of plastic, rubber, or silicone and may be packaged with a connector that attaches to a breathing circuit and is available in two basic configurations: 1) a double lumen tube with independent cuffs at the distal end for ventilation of the left or right bronchi; or 2) a twin lumen tube with independent cuffs for selective lung ventilation during thoracic surgery or postoperative care when independent lung ventilation is indicated. This is a single-use device.

Recalls

Date	Firm	Reason
2024-09-16	Ambu Inc.	Ambu has received complaints on Ambu VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intub
2022-06-03	Ambu Inc.	Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will r
2019-10-30	Teleflex Medical	The tracheal and brochial swivel connectors are incorrectly labeled.
2016-12-16	Parker Medical	The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.
2015-06-01	Teleflex Medical	The double swivel connector may crack or separate on the endobronchial tube.
2015-06-01	Teleflex Medical	The double swivel connector may crack or separate on the endobronchial tube.
2015-06-01	Teleflex Medical	The double swivel connector may crack or separate on the endobronchial tube.
2015-06-01	Teleflex Medical	The double swivel connector may crack or separate on the endobronchial tube.
2005-02-23	Teleflex Medical	The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and catalog number 5-161
2005-02-23	Teleflex Medical	The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and catalog number 5-161

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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.