Recall archive
444 recalls · page 15 of 19
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)
Reported Mar 9, 2016
Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtronic Perfusion Systems
Matched: Brand · Product · Product details · Reason for recall — Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected…
FDA (openFDA device enforcement)
Reported Mar 2, 2016
Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening…
FDA (openFDA device enforcement)
Reported Feb 24, 2016
Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic
Matched: Brand — Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 23, 2015
MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed Inc.
Matched: Brand — The pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 9, 2015
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details · Reason for recall — Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high…
FDA (openFDA device enforcement)
Reported Dec 2, 2015
Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA, Inc. - Dallas Distribution
Matched: Brand — The wire pass hole is not present on the tools.
FDA (openFDA device enforcement)
Reported Nov 18, 2015
Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is…
FDA (openFDA device enforcement)
Reported Nov 18, 2015
Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Reason for recall — Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the…
FDA (openFDA device enforcement)
Reported Nov 11, 2015
Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — 64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
FDA (openFDA device enforcement)
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