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TRACOE® twist plus

Tracoe medical GmbH · Model REF 316-10-P · UDI-DI 04035324019243

JOH Prescription

510(k) clearances

14,926

Adverse events (164 deaths)

131

Recalls

Facilities

Description

TRACOE twist plus Tracheostomy Tube, Double Fenestrated, with Low Pressure Cuff and Subglottic Suction Line, with atraumatic insertion system

Recalls

Date	Firm	Reason
2026-04-15	Covidien LLC	Due to customer complaint regarding incorrect display box labeling.
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2025-02-26	Covidien	Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspeci
2023-08-22	Smiths Medical ASD Inc.	The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).
2023-04-07	Cook Incorporated	There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories.
2023-04-07	Cook Incorporated	There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories.
2023-03-24	Covidien	A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15m

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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.