Shiley™ Adult Flexible Tracheostomy Tubes with Taperguard™ Cuff and Cuffless

Medtronic is initiating a voluntary recall for specific production lots of Shiley™ Adult Flexible Tracheostomy Tubes with Taperguard™ Cuff and Cuffless with disposable or reusable inner cannulas. This recall follows reports from customers that the device connector in some instances is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. (models/device identifiers are provided in above table).

Since the implementation of the connector component in march of 2021, there have been 69 customer reports (64 reports since July 2022) of the connector not making a secure connection with the 15mm cap (sku: cap) and other 15mm breathing circuit components and accessories. 59

complaints are related to the 15mm cap and other non-breathing circuit related accessories, 9 complaints for breathing circuits and related components, and 1 complaint of connection failure with an unknown device. While no serious patient harm was associated with these devices, dyspnea, a delay to treatment while an alternate device was obtained, and minor tissue injury and bleeding were reported. There may exist the potential for respiratory failure; however, no reports of this occurrence have been reported to Medtronic. of note, 19 complaints out of the 69 originated from Canada, all of which involved no patient harm.

Investigation of these customer reports identified a manufacturing error, which resulted in a less than specified diameter of the connector component of specific Shiley™ Adult Flexible Tracheostomy Tubes. This resulted in an unsecure connection between the device connector and circuit components, cap or accessories.

A calibrated ring gauge is used for the inspection of 15mm connectors during device production. The steps on the gauge indicate the lower, nominal, and upper limit specifications of the 15mm connector. Investigation of 15mm connector samples shows the connector measuring at the low side of the diameter specification, or upper limit of ring gauge. Initial investigations show that some connector samples do not meet this specification.

The issue is most prevalent when connecting the 15mm cap (cap), or other accessories that have limited depth in which to engage the taper of the connectors, and less with deeper connectors and connectors without a stop (e.g., circuit tubing), which can travel farther down the connector to a point where the taper of the connectors make a secure connection.

Recall start date: March 27, 2023