Recall archive
81 recalls · page 2 of 4
Reported May 12, 2021
Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — Incorrect size printed on the device; packaging is labeled correctly.
FDA (openFDA device enforcement)
Reported Apr 7, 2021
Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S…
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 — A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 3, 2021
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter…
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 — Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 20, 2021
CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency…
FDA (openFDA device enforcement)
Reported Dec 9, 2020
MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Missing solder battery connection, which could interrupt power of insulin pump.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2020
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped…
FDA (openFDA device enforcement)
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 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 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 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 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 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 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)
Reported Feb 27, 2019
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
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 — There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic…
FDA (openFDA device enforcement)
Reported Feb 20, 2019
Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number…
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 · Product · Product details · Reason for recall — A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 13, 2019
MEDTRONIC CARELINK 2090 programmer
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 — There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 2, 2019
Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens.…
FDA (openFDA device enforcement)
Reported Nov 14, 2018
Medtronic CareLink 2090 Programmer
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 — Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with…
1 more product in this recall
FDA (openFDA device enforcement)
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 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)
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