BEUDAMED
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    Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code GZB·July 29, 2014

    Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code GZB·July 29, 2014

    St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Recall
    Terminated ·Abbott·Product code MXC·November 19, 2018

    Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code BRY·January 15, 2016

    ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code LWS·June 20, 2019

    ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code LWS·June 20, 2019

    The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.

    FDA Recall
    Terminated ·Advanced Neuromodulation Systems Inc.·Product code LGW·September 4, 2012

    ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code LWS·June 20, 2019

    ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code LWS·June 20, 2019

    ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code LWS·June 20, 2019

    ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code LWS·June 20, 2019

    Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA. The Pyxis Anesthesia Station 3500 is a medication dispensing product that provides medication and inventory management for the anesthesiologist at the point of care within the operating room. The system tracks and stores controlled substances, medications and supplies for anesthesia providers and automates verification of patient usage records, documents waste, manages inventory levels and tracks utilization.

    FDA Recall
    Terminated ·Cardinal Health Manufacturing LLC·Product code BRY·December 24, 2008

    Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo is a re-usable pen injector for single patient use by diabetics for the self injection of a desired dose of insulin. The pen injector uses Penfill 3 mL cartridge of NovoLog, 100 units/mL (Ux100) [insulin aspart (rDNA origin) injection] and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 increments.

    FDA Recall
    Terminated ·Novo Nordisk Inc·Product code FMF·July 5, 2017

    Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code MHY·September 12, 2017

    Proclaim DRG Implantable Pulse Generator Model 3664

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code LGW·September 12, 2017

    Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code LGW·September 12, 2017

    St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano, TX St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 40 cm, 0.5 REF 6172 STERILE EO Rx ONLY St. Jude Medical Plano, TX Instructions For Use: Lead and Extension Kits for Deep Brain Stimulation Systems Clinician's Manual ST. JUDE MEDICAL - Product Usage: St. Jude Medical Deep Brain Stimulation (DBS)leads are intended to deliver stimulation to target areas in the brain. DBS extensions are intended to connect the leads to implantable pulse generators (IPGs). St. Jude Medical DBS leads are designed for introduction into the brain using standard stereotactic neurosurgical techniques. DBS system delivers electrical stimulation to a precisely targeted area in the brain. Leads are implanted in the brain and are connected to extensions, which are passed under the skin and are connected to the neurostimulator. Leads for the St. Jude Medical Infinity DBS System feature electrodes on a stiff distal end with an inactive lead tip. The proximal end of the lead contains contact bands that correspond with each of the distal electrodes and an inactive band that functions as a contact for a setscrew when connecting to a compatible extension. The 8-channel leads contain cylindrical and segmented electrodes. The segmented electrodes can be activated independently to focus stimulation in one direction to help target desired neurological structures. As stated in Clinician manual (ARTEN600008305 Rev A), leads materials which are intended to come into contact with tissue are Platinum-iridium and polycarbonate urethane. In addition, drawing for the Stim Tip, 1-3-3-1 Directional DBS lead requires that the electrode material shall be 90/10 Platinum Iridium.

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code MHY·October 11, 2018