Medtronic recalls

Medtronic is recalling 3 related products used to program and check Medtronic cardiac implantable devices: the CareLink SmartSync Device Manager App (M01A02), the Programmer 24970A, and the RF Head 24967 Patient Connector and RF Head 24967 EUR MKT. Bluetooth disconnections may occur between the device manager software and its accessories, and during a SmartSync patient session this may lead to undesirable or incomplete parameter programming that could cause harm. No injuries have been reported.

Moderate·FDA·Nov 6, 20263 products

Medtronic is recalling three CareLink SmartSync products, including the programmer, RF head patient connector and Device Manager app, because a software problem can cause an inaccurate displayed longevity estimate for implanted pulse generators. No injuries have been reported. The recall covers about 61,000 units distributed worldwide.

Moderate·FDA·Oct 27, 20263 products

Medtronic has recalled certain OmniaSecure Model 3930M ventricular leads (used in heart devices for pacing and defibrillation) due to reports of difficulty achieving proper fixation during implantation. This implantation difficulty could potentially cause tissue trauma during the surgical procedure.

Moderate·FDA·Oct 23, 2026

Medtronic is recalling two product groups in its InterStim system: InterStim SureScan MRI leads and InterStim percutaneous extensions. The recall covers 2 products in total. The company says the wrong lead or extension may have been selected, and an incompatible one may stop the system from working as intended. This could delay surgery or require surgical replacement of the product. No injuries have been reported.

Moderate·FDA·Oct 22, 20262 products

A software bug in MiniMed Go version 1.2.1 broke the long-acting insulin dose reminder feature for users who had it enabled in earlier versions. When users updated the app, the reminder stopped working silently—without any alert to the user. This could cause users to miss or delay insulin doses, or accidentally take a double dose if they're unsure whether they already dosed.

Moderate·FDA·Oct 22, 2026

Medtronic MiniMed CareLink Clinic software version 4.4A has a defect in its Settings Calculator feature. When healthcare providers enter custom insulin values, the calculator ignores them and continues using default values instead. This can result in incorrect insulin dose recommendations being sent to patients' insulin pumps, potentially causing patients to receive too much or too little insulin.

Serious·FDA·Oct 21, 2026

Medtronic found that the donor tissue used in batch A62881 did not meet its microbial screening requirements, and donor bone tested positive for Clostridium butyricum. Although the tissue was gamma irradiated and the finished batch passed sterility testing, implanting it could lead to a Clostridium infection. The recall covers two products, and no injuries have been reported.

Moderate·FDA·Oct 21, 20262 products

Medtronic Navigation is recalling four products: certain NDI passive spheres and a biopsy needle kit. The reflective material on these items may vary, which could affect a navigation system's ability to detect and track them. No injuries have been reported.

Moderate·FDA·Oct 16, 20264 products

Some MiniMed Flex insulin pumps were shipped without completing required quality verification tests. These pumps may have problems including failure to work at startup, moisture damage, slow charging, connection issues with glucose monitors or the app, missed occlusion alerts, weak alarm sounds, or inaccurate insulin delivery.

Serious·FDA·Oct 14, 2026

Medtronic is recalling three MiniMed insulin pump models (640G, 670G, and 780G) that were loaned out and may have been cleaned with products that are incompatible with the pump. This could damage the case or keypad, let moisture in, and cause the pump to deliver too much or too little insulin. No injuries have been reported. The recall covers 280 affected pumps and was distributed in several European countries.

Moderate·FDA·Aug 26, 20263 products

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.

Moderate·FDA·Jul 29, 2026

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.

Moderate·FDA·Jul 29, 2026

Medtronic is recalling two cardiopulmonary bypass cannula products after receiving two complaints of loose foreign material, which was confirmed to contain trace amounts of blood. No injuries have been reported. The recall covers two products and was distributed nationwide in several US states as well as worldwide.

Moderate·FDA·Jul 22, 20262 products

Medtronic recalled three models of its Octopus tissue stabilizers, covering 1,012 units in total. During manufacturing, the company found that the tubing was attached backwards, with the short tube on the bottom of the canister and the long tube on top. No injuries have been reported.

Moderate·FDA·Jul 1, 20263 products

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.

Moderate·FDA·Jun 24, 2026

A limited number of Medtronic 1x4 Pocket Adaptor Kits (Models 64001 and 64002) used in deep brain stimulation devices are labeled with incorrect Use-By-Dates. The mislabeled kits may no longer be safe or effective for their intended use.

Moderate·FDA·Jun 3, 20262 products

Medtronic is recalling nine models of retrograde cannulas used in cardiopulmonary bypass procedures. Certain lots may have a sterile barrier that could be breached, which could compromise the product's sterility. No injuries have been reported.

Moderate·FDA·May 27, 20269 products

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.

Moderate·FDA·May 20, 2026

Medtronic is recalling 14 MiniMed insulin pump models, including the Paradigm, 600 series, and BLE 700 series. Changes in pump height relative to the infusion site can cause the pump to deliver too much or too little insulin. No injuries have been reported.

Serious·FDA·Apr 8, 202614 products

Medtronic has recalled certain MiniMed 780G insulin pumps due to software defects that can cause the pump to deliver too much insulin, too little insulin, or stop delivering insulin entirely. These defects appeared after software updates (versions 6.60, 6.61, and 6.62) and may result in dangerously high or low blood sugar levels. The recall affects over 26,000 pumps with specific serial numbers.

Serious·FDA·Apr 1, 2026

Medtronic found a manufacturing error in 2 units of the Octopus Nuvo Tissue Stabilizer where the tubing was installed backwards—the short tube was attached to the bottom and the long tube to the top, opposite of the correct design. This could affect how the device functions during use.

Moderate·FDA·Mar 4, 2026

Some Medtronic MiniMed 780G insulin pumps with software version 6.60 may experience a software timing issue that triggers an error code and stops insulin delivery. This affects specific catalog numbers (MMT-1884, MMT-1886) with certain serial numbers.

Serious·FDA·Feb 11, 2026

Medtronic has recalled certain Abre Venous Self-Expanding Stents due to a manufacturing issue with the stent material (Nitinol) that can cause the stent to be smaller than intended when deployed. This reduced size may result in the stent moving out of position after placement.

Moderate·FDA·Jan 21, 2026

A software problem in the Medtronic Restore Clinician Programmer App (versions before v.1.0.4489) can cause a Device Reset message that cannot be cleared. In rare cases, this prevents the pain management device from resuming therapy, causing patients to experience pain symptoms again. The implanted devices themselves are not affected—only the programmer application used by clinicians.

Moderate·FDA·Dec 31, 2025

Medtronic MiniMed InPen App users on Android (versions 7.5.0, 7.5.1, and 8.0.0) may lose insulin reminders if they uninstall and reinstall the app. The notification settings screen doesn't appear during setup, preventing notifications from overriding your phone's mute or Do Not Disturb mode. This could delay insulin therapy.

Moderate·FDA·Dec 24, 2025

There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.

FDA·Dec 10, 2025

Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.

FDA·Dec 3, 2025

Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

FDA·Dec 3, 2025

Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.

FDA·Nov 26, 2025

As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.

FDA·Nov 26, 2025