Recall archive
444 recalls · page 12 of 19
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)
Reported Feb 14, 2018
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details · Reason for recall — Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
FDA (openFDA device enforcement)
Reported Jan 31, 2018
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The…
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 — Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2018
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
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 directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal…
FDA (openFDA device enforcement)
Reported Dec 6, 2017
Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Stent length on the label may not match the length of the stent itself.
FDA (openFDA device enforcement)
Reported Nov 29, 2017
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details · Reason for recall — Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 25, 2017
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.
FDA (openFDA device enforcement)
Reported Oct 4, 2017
Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product · Product details — It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two…
FDA (openFDA device enforcement)
Reported Sep 27, 2017
Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 27, 2017
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular Galway dba Medtronic Ireland
Matched: Brand — Stylette removal difficulties on the Euphora and Solarice products.
1 more product in this recall
FDA (openFDA device enforcement)
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