Recall archive
453 recalls · page 6 of 19
Reported Feb 8, 2023
AxiEM" Non-Invasive Patient Tracker
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to…
FDA (openFDA device enforcement)
Reported Feb 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 18, 2023
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
Matched: Reason for recall — DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic…
FDA (openFDA device enforcement)
Reported Jan 18, 2023
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
FDA (openFDA device enforcement)
Reported Jan 18, 2023
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 11, 2023
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed
Matched: Brand — An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not…
FDA (openFDA device enforcement)
Reported Dec 28, 2022
HeartWare Model 1100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heartware, Inc.
Matched: Reason for recall — Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 23, 2022
Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
Matched: Reason for recall — Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 23, 2022
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — Due to a defect in the outer pouch sterile seal
FDA (openFDA device enforcement)
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)
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