Recall archive
444 recalls · page 8 of 19
Reported Jul 28, 2021
Medtronic Reveal LINQ LNQ11 / PA96000
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 — Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report…
FDA (openFDA device enforcement)
Reported Jul 21, 2021
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
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 — Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
FDA (openFDA device enforcement)
Reported Jul 14, 2021
CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Heart Valves Division
Matched: Brand — Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 7, 2021
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand — Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — Specific lots may have been manufactured with insufficient or incomplete welds.
24 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular
Matched: Brand — The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped…
FDA (openFDA device enforcement)
Reported Jun 16, 2021
Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA, Inc.
Matched: Brand — Product is impacted by a thread profile defect due to a manufacturing issue.
FDA (openFDA device enforcement)
Reported Jun 9, 2021
MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG; KIT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Minimed
Matched: Brand — Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 26, 2021
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand — The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
FDA (openFDA device enforcement)
Reported May 26, 2021
Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor…
19 more products in this recall
FDA (openFDA device enforcement)
Reported May 19, 2021
VenaSeal Closure System
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtronic Inc.
Matched: Brand — Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery…
FDA (openFDA device enforcement)
Reported May 12, 2021
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
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 SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month…
5 more products in this recall
FDA (openFDA device enforcement)
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 May 12, 2021
Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
FDA (openFDA device enforcement)
Reported Apr 28, 2021
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Heartware, Inc.
Matched: Reason for recall — Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation,…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 28, 2021
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA, Inc.
Matched: Brand — The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 14, 2021
Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Heartware, Inc.
Matched: Product · Product details — There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 14, 2021
A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — There are two issues within this correction action: 1. Cycling Issue: When copying settings from a previously used Activa device to a new Percept PC…
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 Apr 7, 2021
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to…
FDA (openFDA device enforcement)
Reported Mar 24, 2021
Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 17, 2021
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular, Inc.
Matched: Brand — Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
FDA (openFDA device enforcement)
Reported Mar 17, 2021
Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular
Matched: Brand · Product · Product details — Sterility may be compromised due to an unsealed pouch
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 24, 2021
Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
Matched: Brand · Product · Product details — Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the…
2 more products in this recall
FDA (openFDA device enforcement)
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