Recall archive
453 recalls · page 14 of 19
Reported Apr 19, 2017
The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neurosurgery
Matched: Brand · Product · Product details — Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the StrataMR Locator Tool: When the StrataMR valve is set in…
FDA (openFDA device enforcement)
Reported Apr 19, 2017
Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Reason for recall — AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be…
17 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 5, 2017
SynchroMed II implantable drug infusion pump, Model 8637-40,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Reason for recall — Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted…
FDA (openFDA device enforcement)
Reported Mar 29, 2017
Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 29, 2017
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Reason for recall — Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific…
FDA (openFDA device enforcement)
Reported Mar 22, 2017
BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic
Matched: Brand — Handle may break during use.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 8, 2017
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card,…
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 following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating…
FDA (openFDA device enforcement)
Reported Mar 8, 2017
Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B.
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 of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits…
123 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 8, 2017
Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Advanced Energy, LLC
Matched: Brand — Product sterility compromised due to breach of sterile barrier
10 more products in this recall
FDA (openFDA device enforcement)
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)
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