Recall archive
453 recalls · page 4 of 19
Reported Sep 18, 2024
Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand · Product · Product details — Product was distributed past expiration date.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
TourniKwik Tourniquet Set (CFN 79012)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Xomed, Inc.
Matched: Brand — Potential for false negative response on the NIM Vital Nerve Monitoring System
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue…
FDA (openFDA device enforcement)
Reported Jul 3, 2024
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
22 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2024
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand — Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay,…
FDA (openFDA device enforcement)
Reported May 22, 2024
Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP¿…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — Potential for unsealed sterile packing.
12 more products in this recall
FDA (openFDA device enforcement)
Reported May 15, 2024
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand — Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point"…
FDA (openFDA device enforcement)
Reported May 8, 2024
Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien
Matched: Product · Product details — manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 8, 2024
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — inability to reprogram one device
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — There is a potential for sterile package breach.
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Medtronic DLP Vessel Cannula, Model Number REF 30000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details · Reason for recall — Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed…
FDA (openFDA device enforcement)
Reported Mar 6, 2024
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neurosurgery
Matched: Brand · Product · Product details — Potential for catheter disconnection from the patient line stopcock connectors.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand — Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 ¿m). A non-conforming GOX layer thickness could…
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone…
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Model A710 Intellis Clinician Programmer Application, version 2.0.97
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Reason for recall — Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with…
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand — Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve…
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Seal defects could compromise the ability of the product packaging to maintain sterility.
FDA (openFDA device enforcement)
Reported Jan 3, 2024
Medtronic SynchroMed II, Model 8637-20, Programmable pump
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan,…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Medtronic SynchroMed, Model A10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of…
FDA (openFDA device enforcement)
Reported Dec 6, 2023
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart…
FDA (openFDA device enforcement)
Reported Nov 29, 2023
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label…
2 more products in this recall
FDA (openFDA device enforcement)
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