Recall archive
453 recalls · page 15 of 19
Reported Aug 24, 2016
Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 The Valleylab Laparoscopic Handset and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic
Matched: Brand — Potential for compromise of the package resulting in a breach of the sterile barrier
24 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 10, 2016
Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Reason for recall — Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 27, 2016
Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Centurion Medical Products Corporation
Matched: Product · Product details · Reason for recall — Kits from Centurion contain a Medtronic/Covidien Light Glove that is being recalled by the manufacturer, Medtronic. According to the notice received…
FDA (openFDA device enforcement)
Reported Jul 20, 2016
Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure
Matched: Brand · Product · Product details — This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of FDA 21 CFR 898, which relate to design…
FDA (openFDA device enforcement)
Reported Jul 13, 2016
Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LLC
Matched: Reason for recall — Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2016
Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure
Matched: Brand · Product · Product details · Reason for recall — Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Monitors. After release, Medtronic identified an issue…
FDA (openFDA device enforcement)
Reported Jul 13, 2016
Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand · Product · Product details — It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2016
PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation
Matched: Brand · Reason for recall — Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because of misplaced ground pins which may cause electrical…
FDA (openFDA device enforcement)
Reported Jul 6, 2016
Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA, Inc. - Dallas Distribution
Matched: Brand · Reason for recall — Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during…
FDA (openFDA device enforcement)
Reported Jun 29, 2016
EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ev3, Inc.
Matched: Reason for recall — Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two Protege EverFiex"…
FDA (openFDA device enforcement)
Reported Jun 15, 2016
Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior to obtaining recharge threshold voltage of 3.615,…
FDA (openFDA device enforcement)
Reported Jun 8, 2016
Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Product details · Reason for recall — These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 25, 2016
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
FDA (openFDA device enforcement)
Reported May 18, 2016
Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic
Matched: Brand · Reason for recall — Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 11, 2016
Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure
Matched: Brand · Product · Product details · Reason for recall — A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLink Express Monitors included incorrect data on the…
FDA (openFDA device enforcement)
Reported May 11, 2016
Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA, Inc. - Dallas Distribution
Matched: Brand · Product · Product details — Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
FDA (openFDA device enforcement)
Reported May 4, 2016
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ev3, Inc.
Matched: Reason for recall — Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" ¿ Over the Wire (OTW) Percutaneous Transluminal…
FDA (openFDA device enforcement)
Reported Apr 27, 2016
CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed Inc.
Matched: Brand · Reason for recall — Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard…
FDA (openFDA device enforcement)
Reported Apr 6, 2016
Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Reason for recall — Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended…
FDA (openFDA device enforcement)
Reported Apr 6, 2016
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intrathecal Catheter kit. We have identified that this…
FDA (openFDA device enforcement)
Reported Mar 30, 2016
BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product details · Reason for recall — Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from…
FDA (openFDA device enforcement)
Reported Mar 23, 2016
Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Matched: Reason for recall — Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Covidien Respiratory and Monitoring…
FDA (openFDA device enforcement)
Reported Mar 23, 2016
Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien Medical Products (Shanghai) Manufacturing LLC
Matched: Reason for recall — Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint" Percutaneous Antenna with Thermosphere" Technology…
FDA (openFDA device enforcement)
Reported Mar 16, 2016
Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm¿ 02 Imaging System, causing…
FDA (openFDA device enforcement)
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