Recall archive
444 recalls · page 10 of 19
Reported May 13, 2020
Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector…
FDA (openFDA device enforcement)
Reported Apr 22, 2020
NavLock Tracker *** Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — Product was incorrectly assembled which could affect navigation accuracy of the device.
FDA (openFDA device enforcement)
Reported Apr 1, 2020
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Ats Medical, Inc.
Matched: Brand · Product · Product details · Reason for recall — Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral.…
FDA (openFDA device enforcement)
Reported Apr 1, 2020
MiniMed Insulin Pump, model # MMT-508
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed
Matched: Brand — The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate…
15 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 25, 2020
Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details · Reason for recall — Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 18, 2020
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic CoreValve LLC
Matched: Brand · Product · Product details — Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 11, 2020
McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, PLC
Matched: Brand — Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles which may result in a change in optical performance…
FDA (openFDA device enforcement)
Reported Feb 19, 2020
Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc.
Matched: Brand · Product · Product details — There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 8, 2020
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand · Reason for recall — Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may…
FDA (openFDA device enforcement)
Reported Jan 1, 2020
Lamicel 20PK 3MM INTL Cervical dilator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand — Routine sterilization dose does not meet the required Sterility Assurance Level.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2019
Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and…
FDA (openFDA device enforcement)
Reported Dec 25, 2019
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
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 has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
FDA (openFDA device enforcement)
Reported Dec 18, 2019
Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 11, 2019
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neuromodulation
Matched: Brand — There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and…
FDA (openFDA device enforcement)
Reported Nov 13, 2019
Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc.
Matched: Brand — There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2019
Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
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 — There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2019
Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular Galway dba Medtronic Ireland
Matched: Brand · Reason for recall — Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular
Matched: Brand — There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa…
190 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2019
Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details · Reason for recall — Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2019
Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand · Product · Product details — The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly,…
FDA (openFDA device enforcement)
Reported Jul 3, 2019
Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 19, 2019
InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart…
FDA (openFDA device enforcement)
Reported May 15, 2019
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter…
FDA (openFDA device enforcement)
Reported Apr 3, 2019
Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
FDA (openFDA device enforcement)
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