Recall archive
453 recalls · page 12 of 19
Reported Sep 26, 2018
Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and distributed. This meter contains the incorrect unit of…
FDA (openFDA device enforcement)
Reported Aug 15, 2018
Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Product · Product details — This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on…
FDA (openFDA device enforcement)
Reported Jul 25, 2018
Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien Medtronic
Matched: Brand — Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line…
13 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 25, 2018
Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Reason for recall — Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fibers were not tested at intended laser power levels,…
FDA (openFDA device enforcement)
Reported Jul 25, 2018
Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product details — This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit, to have a potential manufacturing…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 18, 2018
Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand — Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 11, 2018
Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — The MiniMed Paradigm Veo insulin pump has an error that impacts the Arabic language translation.This translation error occurs in the Predictive…
FDA (openFDA device enforcement)
Reported Jul 4, 2018
Single Chamber Temporary External Pacemaker, Model 53401
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Reason for recall — A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use…
FDA (openFDA device enforcement)
Reported Jun 6, 2018
Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Heartware
Matched: Product · Product details — Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller,…
FDA (openFDA device enforcement)
Reported May 23, 2018
Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450) Product Usage: The Endo GIA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien Medtronic
Matched: Brand — Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line…
39 more products in this recall
FDA (openFDA device enforcement)
Reported May 16, 2018
Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Product · Product details — The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 2, 2018
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular
Matched: Brand · Product · Product details — The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters…
FDA (openFDA device enforcement)
Reported Apr 4, 2018
6F Taiga Guiding Catheter
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc.
Matched: Brand — Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting.
FDA (openFDA device enforcement)
Reported Mar 21, 2018
Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Minimally Invasive Therapies Group
Matched: Brand — Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as the Salem Sump Dual Lumen Stomach Tube. This…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 14, 2018
O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand — During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is possible that the high-power cable connector may come…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 14, 2018
Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design…
FDA (openFDA device enforcement)
Reported Mar 14, 2018
BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Reason for recall — Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and expectations. As a result, an updated cleaning…
FDA (openFDA device enforcement)
Reported Feb 28, 2018
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Reason for recall — Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2018
Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro software using the new CareLink iPro Uploader feature…
FDA (openFDA device enforcement)
Reported Feb 28, 2018
Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2018
Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
Matched: Brand · Product · Product details · Reason for recall — Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to…
FDA (openFDA device enforcement)
Reported Feb 21, 2018
Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Product · Product details · Reason for recall — Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print…
FDA (openFDA device enforcement)
Reported Feb 14, 2018
Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
Matched: Reason for recall — Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood…
FDA (openFDA device enforcement)
Reported Feb 14, 2018
Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtronic Neuromodulation
Matched: Brand · Product · Product details — There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at…
FDA (openFDA device enforcement)
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