Recall archive
453 recalls · page 9 of 19
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)
Reported Feb 10, 2021
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Heartware, Inc.
Matched: Product · Product details — Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in…
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 27, 2021
REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
Matched: Brand · Product · Product details — Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to…
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 Jan 20, 2021
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
FDA (openFDA device enforcement)
Reported Jan 6, 2021
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
Matched: Brand · Product · Product details — There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 23, 2020
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
FDA (openFDA device enforcement)
Reported Dec 16, 2020
Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Heart Valves Division
Matched: Brand — Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
2 more products in this recall
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 Dec 2, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Ats Medical, Inc.
Matched: Brand — There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 28, 2020
Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular
Matched: Brand — Subsequent failure of catheters in the field and failed quality testing
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 Aug 5, 2020
StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation…
FDA (openFDA device enforcement)
Reported Jul 29, 2020
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 29, 2020
Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand — During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was…
FDA (openFDA device enforcement)
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