Recall archive
453 recalls · page 7 of 19
Reported Jun 1, 2022
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
FDA (openFDA device enforcement)
Reported May 25, 2022
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the…
FDA (openFDA device enforcement)
Reported May 18, 2022
Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product · Product details — Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 4, 2022
Puritan Bennett 980 Series Ventilator
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic formerly Covidien
Matched: Brand — The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states…
FDA (openFDA device enforcement)
Reported May 4, 2022
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields…
FDA (openFDA device enforcement)
Reported Apr 27, 2022
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc.
Matched: Brand — There is potential for the capsule bond to break during the procedure.
FDA (openFDA device enforcement)
Reported Apr 27, 2022
Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand · Reason for recall — As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was…
FDA (openFDA device enforcement)
Reported Apr 6, 2022
MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed
Matched: Brand — New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.),…
FDA (openFDA device enforcement)
Reported Mar 23, 2022
LINQ II Insertable Cardiac Monitor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand — Devices may lose functionality due to susceptibility to moisture ingress.
FDA (openFDA device enforcement)
Reported Mar 16, 2022
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ev3 Inc.
Matched: Product · Product details — The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 16, 2022
NIM TRIVANTAGE EMG Endotracheal Tube
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand — There is potential for multiple issues due to a manufacturing nonconformity.
FDA (openFDA device enforcement)
Reported Mar 2, 2022
Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product · Product details — Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system.…
FDA (openFDA device enforcement)
Reported Jan 26, 2022
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ev3 Inc.
Matched: Product · Product details — Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 19, 2022
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — Product is labeled as non-pyrogenic but endotoxin testing was not performed.
FDA (openFDA device enforcement)
Reported Jan 12, 2022
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — There have been reports of stent migration.
FDA (openFDA device enforcement)
Reported Jan 5, 2022
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Reason for recall — During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a…
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand — Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 22, 2021
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand — The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — The processing of collected episode data may fail due to a software error.
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Cardioblate CryoFlex Surgical Ablation Console
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — There is potential for intermittent electrical connectivity between the console and probe.
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand — During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 10, 2021
Clinician Programmer Application (CPA) model A610 Clinician Software Application
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — A software anomaly may occur with the clinician programmer application.
FDA (openFDA device enforcement)
Reported Nov 3, 2021
C315-HIS Delivery Catheter
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Reason for recall — Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
FDA (openFDA device enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up