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Reports of system error during preoperative calibration self-tests of the Hugo robotic arm cart assembly. After recalibration attempt, the robotic arm cart assembly will be prevented from entering teleoperation even if the calibration is successful. This…

During manufacturing related testing, the catheter center lumen was found to have an occlusion in the tip of the catheter. The source of the occlusion is excessive mdx, a silicone-based lubricant which coats the catheter tip. Recall Start Date: June…

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…

Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Recall start date: March 1, 2023

Starting in September 2022, customers reported tracheal tube inflation system leaks. Medtronic's investigation identified a manufacturing assembly error which resulted in an incomplete closure of the inflation system. Recall start date: February 10,…

Specific lots have the potential for a broken sled vane component. A broken sled vane may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may…

During the production process, a potential internal leaking condition within the hub of specific Mahurkar acute dual lumen high flow  hemodialysis catheter was identified as a result of a void in the catheter hub. During dialysis, this observed…

Medtronic has determined that there were manufacturing errors in the packaging of the listed nonabsorbable sutures that may cause a gap or wrinkle in the breather pouch seal resulting in a sterile barrier breach. The potential harms of a sterile barrier…

Needle may break during endoscopic suturing.  Recall start date: September 28, 2022

Medtronic is issuing a voluntary medical device correction related to specific serial numbers of the turbine component of Puritan Bennett 500 series ventilators. This voluntary medical device correction is being issued following confirmation of six…

Medtronic has identified a potential leaking condition within the hub of specific chronic hemodialysis catheters. Flushing one extension tube may result in unanticipated fluid return through the adjacent extension tube (in addition to the anticipated…

Notification to inform customers regarding potential for the staple guide to not be securely attached to the instrument. A staple guide not attached to the instrument could cause the component to disengage and if disengaged, could allow the device to…

Potential for blood leak to occur with the anti-reflux valve upon treatment completion. Recall start date: May 5, 2022.

During alarm conditions, the audible alarm may not sound and/or the omnidirectional led visual alarm may not illuminate as described in the operator's manual. Recall start date: Apr 1, 2022

Potential non-recoverable error during Arm Cart Assembly calibration self-test leading to a delay to the surgical procedure. Recall start date: Mar 21, 2022