Recall archive
453 recalls · page 5 of 19
Reported Nov 29, 2023
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
FDA (openFDA device enforcement)
Reported Nov 15, 2023
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand — Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
FDA (openFDA device enforcement)
Reported Nov 8, 2023
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer…
FDA (openFDA device enforcement)
Reported Nov 1, 2023
Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 25, 2023
SenSight Connector Plug, Model Number B31061.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Reason for recall — Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD)…
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy…
FDA (openFDA device enforcement)
Reported Sep 20, 2023
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — The incorrect product labeling was applied to the product indicating the wrong size of product.
FDA (openFDA device enforcement)
Reported Aug 30, 2023
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand — Ground cable installed incorrectly.
FDA (openFDA device enforcement)
Reported Aug 23, 2023
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
Matched: Brand · Product · Product details — Product labeling contains incorrect expiration date
FDA (openFDA device enforcement)
Reported Aug 16, 2023
Medtronic InterStim Ground Pad REF 041826
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.
FDA (openFDA device enforcement)
Reported Aug 16, 2023
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA, Inc.
Matched: Brand — Incorrect Laser Marking - Solera Awl Tip Tap
FDA (openFDA device enforcement)
Reported Aug 2, 2023
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version…
FDA (openFDA device enforcement)
Reported Jul 26, 2023
Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
Matched: Brand — Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may…
FDA (openFDA device enforcement)
Reported Jul 19, 2023
Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Product · Product details — There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy.…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LLC
Matched: Product · Product details · Reason for recall — Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied…
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Reason for recall — A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023,…
FDA (openFDA device enforcement)
Reported Jun 28, 2023
HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heartware, Inc.
Matched: Reason for recall — Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and…
FDA (openFDA device enforcement)
Reported Jun 28, 2023
ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators
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 — There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter…
119 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 14, 2023
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand — During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 17, 2023
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause…
FDA (openFDA device enforcement)
Reported Apr 26, 2023
Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result,…
FDA (openFDA device enforcement)
Reported Apr 26, 2023
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 19, 2023
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
Matched: Reason for recall — Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 12, 2023
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Product · Product details — Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a…
11 more products in this recall
FDA (openFDA device enforcement)
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