Recall archive
453 recalls · page 10 of 19
Reported Jul 15, 2020
CareLink SmartSync Device Manager, Model Number 24970A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand — There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 15, 2020
Extra corporeal circuit with bio-active surface.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — Affected products failed a sterilization test.
FDA (openFDA device enforcement)
Reported Jun 24, 2020
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Product details — Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 17, 2020
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling…
FDA (openFDA device enforcement)
Reported Jun 10, 2020
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — Internal testing results showed endotoxin-related test result did not meet specifications for implantable insulin pump. If pumps have higher than…
FDA (openFDA device enforcement)
Reported Jun 3, 2020
Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C 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 — Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or…
FDA (openFDA device enforcement)
Reported Jun 3, 2020
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular Galway dba Medtronic Ireland
Matched: Brand · Product · Product details — Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
FDA (openFDA device enforcement)
Reported May 27, 2020
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of…
FDA (openFDA device enforcement)
Reported May 20, 2020
VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — Nonconforming product; length of the product measured shorter than the labeled length.
FDA (openFDA device enforcement)
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)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up