Recall archive
444 recalls · page 14 of 19
Reported Feb 8, 2017
Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
Matched: Brand · Product · Product details · Reason for recall — Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of…
FDA (openFDA device enforcement)
Reported Jan 18, 2017
Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure
Matched: Brand — During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI…
FDA (openFDA device enforcement)
Reported Jan 18, 2017
AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then…
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 AxIEM Touch N Go Pointer Probe because the patient registration accuracy may…
FDA (openFDA device enforcement)
Reported Jan 4, 2017
NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand — Wire in tubing can become exposed, posing potential harm to the intubated patient.
FDA (openFDA device enforcement)
Reported Dec 28, 2016
Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Reason for recall — Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion¿ Oxygenators with Balance¿1 Biosurface. These are…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 28, 2016
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic
Matched: Brand — Product sterility is compromised due to breach of the sterile barrier
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 14, 2016
Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery 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 an increased number of complaints from customers involving reports of Rechargers (Medtronic Model 37751 Recharger, which is…
FDA (openFDA device enforcement)
Reported Nov 9, 2016
Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are…
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 Visualase Visualization Stylets and Visualase Body Accessory Kit because when…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 26, 2016
Abdominoplasty Pack, Kit number AMS3326 convenience custom kits used for general surgery in hospital operating room
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Reason for recall — The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes…
149 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 19, 2016
Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand · Product · Product details — O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
FDA (openFDA device enforcement)
Reported Oct 5, 2016
CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Reason for recall — Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.
FDA (openFDA device enforcement)
Reported Aug 31, 2016
Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4…
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 — 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 31, 2016
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
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 voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers. During the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 31, 2016
RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 24, 2016
Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Cardiovascular Surgery-the Heart Valve Division
Matched: Brand · Product · Product details · Reason for recall — Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).
FDA (openFDA device enforcement)
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)
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