Recall archive
453 recalls · page 19 of 19
Reported Jul 3, 2013
Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc. Cardiac Rhythm Disease Management
Matched: Brand · Product · Product details · Reason for recall — Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2013
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2013
INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Product · Product details — Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2013
lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Invatec LLC
Matched: Product details — Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.
FDA (openFDA device enforcement)
Reported Jun 12, 2013
REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Xomed, Inc.
Matched: Brand · Product · Product details · Reason for recall — In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which…
FDA (openFDA device enforcement)
Reported Jun 5, 2013
adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.TZ Medical Inc.
Matched: Reason for recall — TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may…
FDA (openFDA device enforcement)
Reported May 22, 2013
PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConMed Corporation
Matched: Product details — ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or…
FDA (openFDA device enforcement)
Reported May 8, 2013
Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 17, 2013
Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed
Matched: Brand · Product · Product details · Reason for recall — Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap may become detached from the pump case and protrude…
FDA (openFDA device enforcement)
Reported Apr 10, 2013
Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic has found through device testing that if the optional footswitch is not connected to the Model 8930 RF generator during use, an…
FDA (openFDA device enforcement)
Reported Apr 3, 2013
Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc. Cardiac Rhythm Disease Management
Matched: Brand · Product · Product details · Reason for recall — Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 20, 2013
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
FDA (openFDA device enforcement)
Reported Mar 13, 2013
Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc. Cardiac Rhythm Disease Management
Matched: Brand · Product · Product details — Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.
FDA (openFDA device enforcement)
Reported Jan 9, 2013
Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc. Cardiac Rhythm Disease Management
Matched: Brand · Product · Product details · Reason for recall — Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain…
FDA (openFDA device enforcement)
Reported Dec 26, 2012
Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), which may contain a damaged winged connector boot.…
FDA (openFDA device enforcement)
Reported Dec 19, 2012
SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neuromodulation
Matched: Brand · Reason for recall — Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 5, 2012
The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product details · Reason for recall — Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading…
FDA (openFDA device enforcement)
Reported Oct 17, 2012
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Product · Product details — Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 19, 2012
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand · Product · Product details · Reason for recall — In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 29, 2012
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.
FDA (openFDA device enforcement)
Reported Jun 27, 2012
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Software Version 3.1.1 does not meet navigational accuracy.
FDA (openFDA device enforcement)
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