Recall archive
444 recalls · page 5 of 19
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)
Reported Feb 8, 2023
AxiEM" Non-Invasive Patient Tracker
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to…
FDA (openFDA device enforcement)
Reported Feb 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 18, 2023
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
Matched: Reason for recall — DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic…
FDA (openFDA device enforcement)
Reported Jan 18, 2023
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
FDA (openFDA device enforcement)
Reported Jan 18, 2023
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 11, 2023
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed
Matched: Brand — An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not…
FDA (openFDA device enforcement)
Reported Dec 28, 2022
HeartWare Model 1100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heartware, Inc.
Matched: Reason for recall — Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 23, 2022
Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
Matched: Reason for recall — Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 23, 2022
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — Due to a defect in the outer pouch sterile seal
FDA (openFDA device enforcement)
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