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Displaying 1 - 15 of 21 items.
Auto Suture Blunt Tip and Structural Balloon Trocar
Medtronic received reports of events related to Covidien Auto Suture™ Structural Balloon Trocar and Auto Suture™ Blunt Tip Trocar reporting trocar seal disengagement when using the trocar with certain mesh products. This issue can occur when the trocar…
RecallHealth product recall | 2024-03-13
Sofsilk™ Braided Silk sutures and Ti-Cron™ Coated Braided Polyester Sutures
Specific lots of the Sofsilk™ Braided Silk sutures and Ti-Cron™ Coated Braided Polyester Sutures were sterilized with gamma doses that exceeded the range approved or were exposed to more than the approved number of Ethylene Oxide (EO) sterilization…
RecallHealth product recall | 2024-01-31
McGRATH™ Mac 2 Laryngoscope Blade
Medtronic received six (6) complaints of poor picture quality and foggy and/or blurred images on the McGRATH™ Mac 2 video laryngoscope screen during use of these blades. The reports indicated a delay to treatment while an alternate device was located and…
RecallHealth product recall | 2024-01-18
Cytosponge™ Cell Collection Device
Specific lot numbers of Cytosponge Cell Collection device may be at increased risk of the sponge detaching from the string during removal of the device from the patient.
Recall Start Date: June 2, 2023
RecallHealth product recall | 2023-12-20
Valleylab FT10 FT Series Energy Platform
Upon insertion of a new (unused) Ligasure™ device, the Valleylab™ FT10 energy platform running software versions 4.0.1, 4.0.2 and 4.0.3 may erroneously indicate that the Ligasure™ device was used previously. When this occurs, the energy platform will…
RecallHealth product recall | 2023-12-05
Hugo™ Robotic-Assisted Surgery (RAS) Tower, 120v
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…
RecallHealth product recall | 2023-09-15
Mahurkar Acute High Pressure Triple Lumen Catheter Kit Curved Extensions
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…
RecallHealth product recall | 2023-07-07
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…
RecallHealth product recall | 2023-04-06
Surgical Gut - Plain and Absorbable Sutures
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
RecallHealth product recall | 2023-03-17
Lo-Pro Tracheal Tube Cuffed Murphy Tip
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,…
RecallHealth product recall | 2023-02-24
Tri-Staple™ 2.0 Black Intelligent Reload
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…
RecallHealth product recall | 2023-02-08
Mahurkar Acute Dual Lumen Catheter Kits
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…
RecallHealth product recall | 2022-12-22
Medtronic Nonabsorbable Sutures
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…
RecallHealth product recall | 2022-12-13
V-Loc PBT Non-Absorbable/180 Absorbable Devices
Needle may break during endoscopic suturing.
Recall start date: September 28, 2022
RecallHealth product recall | 2022-10-14
Puritan Bennett 560 Ventilator
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…
RecallHealth product recall | 2022-08-31