Recall archive
444 recalls · page 4 of 19
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)
Reported Nov 29, 2023
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
FDA (openFDA device enforcement)
Reported Nov 15, 2023
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand — Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
FDA (openFDA device enforcement)
Reported Nov 8, 2023
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer…
FDA (openFDA device enforcement)
Reported Nov 1, 2023
Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 25, 2023
SenSight Connector Plug, Model Number B31061.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Reason for recall — Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD)…
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy…
FDA (openFDA device enforcement)
Reported Sep 20, 2023
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — The incorrect product labeling was applied to the product indicating the wrong size of product.
FDA (openFDA device enforcement)
Reported Aug 30, 2023
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand — Ground cable installed incorrectly.
FDA (openFDA device enforcement)
Reported Aug 23, 2023
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
Matched: Brand · Product · Product details — Product labeling contains incorrect expiration date
FDA (openFDA device enforcement)
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