Recall archive
444 recalls · page 6 of 19
Reported Nov 16, 2022
Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed
Matched: Brand · Reason for recall — Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 28, 2022
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Reason for recall — Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by…
FDA (openFDA device enforcement)
Reported Sep 7, 2022
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
FDA (openFDA device enforcement)
Reported Sep 7, 2022
NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Xomed, Inc.
Matched: Brand — The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 31, 2022
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unexpected Device Error Code 1502 Message, and the user…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 17, 2022
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand — There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 10, 2022
Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
FDA (openFDA device enforcement)
Reported Aug 3, 2022
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand — Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
FDA (openFDA device enforcement)
Reported Jul 20, 2022
MiniMed 620G Insulin Pump (O.U.S. version)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed
Matched: Brand — Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 29, 2022
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc.
Matched: Brand — Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and…
FDA (openFDA device enforcement)
Reported Jun 22, 2022
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1,…
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 — Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 15, 2022
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc.
Matched: Brand — The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld…
FDA (openFDA device enforcement)
Reported Jun 8, 2022
The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand — The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
FDA (openFDA device enforcement)
Reported Jun 8, 2022
NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand — Software anomaly was identified.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 1, 2022
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.
2 more products in this recall
FDA (openFDA device enforcement)
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)
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