Medtronic Inc.

Medtronic MiniMed Go app versions 1.0.0 and 1.1.0 have a software bug: when the "Set day and night" feature is turned off, missed-dose and high-glucose alerts may fail to trigger at night. This means users may not realize they've missed insulin doses, potentially delaying treatment and raising blood sugar levels dangerously.

Medtronic Neurosurgery's Ventriculostomy Kit (REF: 46154) may contain endotoxin levels higher than safe limits for devices that contact cerebrospinal fluid during brain surgery. Endotoxin exposure can trigger acute inflammation in the brain and nervous system.

Medtronic received two complaints of loose foreign material inside the Bio-Medicus Adult Cannula Kit used during heart-lung bypass surgery. Testing confirmed the material contained trace levels of blood. No injuries have been reported.

Medtronic received two complaints of loose foreign material inside the DLP One-Piece Pediatric Arterial Cannula (Product Number 77010), a tube used during heart-lung bypass surgery in children. Testing confirmed the material contained trace levels of blood. No injuries have been reported.

During manufacturing, Medtronic discovered that tubing was installed backwards on some Octopus 4 Tissue Stabilizer devices: the short tube was attached to the bottom of the canister and the long tube to the top, opposite of the correct design. This affects 590 units with specific serial numbers distributed nationwide.

Medtronic identified a manufacturing defect in certain Octopus Evolution AS Tissue Stabilizer units where the tubing was installed backwards—the short tube was attached to the bottom and the long tube to the top, opposite the correct design. This incorrect assembly could affect proper operation during surgical use. The issue affects 288 units distributed worldwide.

Medtronic identified a manufacturing defect in certain Octopus Evolution Tissue Stabilizer units where the tubing was installed backwards: the short tube was attached to the bottom of the canister and the long tube to the top, opposite of the correct design. This incorrect assembly could affect the device's proper function during use.

Medtronic has identified a firmware anomaly in the O-arm O2 Imaging System detector panel that can cause image artifacts during surgical imaging. The issue affects specific serial numbers of the O-arm O2 model BI70002000. No injuries have been reported.

A limited number of Medtronic 2x4 Pocket Adaptor Kits (Models 64001 and 64002) were labeled with incorrect Use-By-Dates. The affected kits are used with deep brain stimulation systems to treat parkinsonian tremor. No injuries have been reported.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94965), a cardiopulmonary bypass catheter, may have a breach in the sterile barrier that protects the device before use. This affects 260 units distributed worldwide, including in the United States.

Certain lots of the Medtronic DLP Retrograde Cannula (Model 94915), a catheter used during heart bypass surgery, may have a breach in their sterile packaging. This could allow contamination before the device is used. No injuries have been reported.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94913L), a catheter used in heart surgery, may have a compromised sterile barrier. This could allow contamination during the surgical procedure. The issue affects 481 units distributed worldwide.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94913), a catheter used in heart-lung bypass surgery, may have a compromised sterile barrier. This could allow contamination before use. The affected product was distributed worldwide, including the United States.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94725), a catheter used in heart surgery, may have a breach in their sterile packaging. This could potentially expose the device to contamination before use. The affected lots have been identified by lot number and GTIN code.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94665) used in heart-lung bypass surgery may have a compromised sterile barrier. This could allow contamination of the device before use. The affected lots have been identified and distributed worldwide.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94215T), a catheter used during heart surgery, may have a compromised sterile barrier. This affects 600 units distributed worldwide. No injuries have been reported.

Certain lots of Medtronic GUNDRY Retrograde Cannula (Model 94115T), a catheter used during heart-lung bypass surgery, may have a breach in their sterile packaging. This could allow contamination of the device before use. The affected lots have been identified and are listed in the recall notice.

Certain lots of Medtronic GUNDRY Retrograde Cannula (Model 94113T), a cardiopulmonary bypass catheter, may have a breach in the sterile barrier. This could allow contamination of the sterile product before use during heart surgery.

A software issue in the A810 Clinician Programmer App can cause infusion steps to display out of order in rare cases. When this happens, the SynchroMed Flex infusion pump may not deliver medication at the intended time, or not deliver it at all. The issue affects specific clinician tablet models running software versions 1.x and 2.x.

Medtronic MiniMed insulin pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin when the pump is held higher or lower than the infusion site on your body. This happens because gravity affects the pressure inside the pump tubing. Incorrect insulin doses can cause serious blood sugar problems.

Medtronic MiniMed insulin pumps (including Paradigm, 600, and 700 series models) may deliver too much or too little insulin when the pump is positioned above or below the infusion site. This happens because gravity affects how insulin flows through the tubing. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar.

Medtronic MiniMed insulin pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin depending on whether the pump is held above or below the infusion site. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar and other serious complications.

Medtronic MiniMed insulin pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin when the pump is held at different heights relative to the infusion site. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar and serious complications.

Medtronic MiniMed insulin pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin depending on whether the pump is positioned higher or lower than your infusion site. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar and other serious complications.

Medtronic MiniMed infusion pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin when the pump is raised or lowered relative to the infusion site. This happens because gravity affects pressure in the pump system. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar and serious complications.

Medtronic MiniMed insulin pumps (including 740G, Paradigm, 600, and 700 series) can deliver too much or too little insulin when the pump is positioned higher or lower than the infusion site on your body. This happens because gravity affects the pressure inside the pump tubing. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar.

Medtronic MiniMed insulin pumps (including MiniMed 720G, Paradigm, 600, and 700 series) can deliver too much or too little insulin depending on whether the pump is positioned above or below the infusion site. Too much insulin can cause dangerously low blood sugar, while too little can cause dangerously high blood sugar.

Medtronic MiniMed insulin pumps (including Paradigm, 600 series, and 700 series models) may deliver too much or too little insulin depending on whether the pump is held above or below the infusion site. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar and related complications.

Medtronic MiniMed insulin pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin when the pump height changes relative to the infusion site. When elevated, excess insulin may cause dangerously low blood sugar. When lowered, insufficient insulin may cause dangerously high blood sugar. This affects about 116,000 pumps worldwide.

Medtronic MiniMed insulin pumps may deliver too much or too little insulin depending on whether the pump is held above or below the infusion site on your body. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar. This happens because gravity affects how insulin flows through the pump.