Recall archive
444 recalls · page 7 of 19
Reported Mar 16, 2022
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ev3 Inc.
Matched: Product · Product details — The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 16, 2022
NIM TRIVANTAGE EMG Endotracheal Tube
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand — There is potential for multiple issues due to a manufacturing nonconformity.
FDA (openFDA device enforcement)
Reported Mar 2, 2022
Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product · Product details — Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system.…
FDA (openFDA device enforcement)
Reported Jan 26, 2022
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ev3 Inc.
Matched: Product · Product details — Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 19, 2022
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — Product is labeled as non-pyrogenic but endotoxin testing was not performed.
FDA (openFDA device enforcement)
Reported Jan 12, 2022
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
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 have been reports of stent migration.
FDA (openFDA device enforcement)
Reported Jan 5, 2022
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Reason for recall — During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a…
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand — Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 22, 2021
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand — The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and…
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 — The processing of collected episode data may fail due to a software error.
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Cardioblate CryoFlex Surgical Ablation Console
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — There is potential for intermittent electrical connectivity between the console and probe.
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand — During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 10, 2021
Clinician Programmer Application (CPA) model A610 Clinician Software Application
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — A software anomaly may occur with the clinician programmer application.
FDA (openFDA device enforcement)
Reported Nov 3, 2021
C315-HIS Delivery Catheter
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 — Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
FDA (openFDA device enforcement)
Reported Oct 27, 2021
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand · Product · Product details — There was an increase in complaints related to tip breaks and wobble/vibration.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — Engraving on implants may not match what is listed on the pouch labels.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
FDA (openFDA device enforcement)
Reported Sep 29, 2021
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — Potential for a wire protrusion through the left heart vent catheter tip
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 22, 2021
Medtronic HVAD Pump Implant Kits
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heartware, Inc.
Matched: Product · Product details — There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair…
FDA (openFDA device enforcement)
Reported Aug 18, 2021
HeartWare HVAD Pump Implant Kit, REF 1103
High riskUsing this product could cause serious injury, illness or death — stop using it now.Heartware, Inc.
Matched: Reason for recall — Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — Excess nylon flash on the clip.
FDA (openFDA device enforcement)
Reported Aug 4, 2021
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile…
FDA (openFDA device enforcement)
Reported Aug 4, 2021
Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product · Product details — During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
1 more product in this recall
FDA (openFDA device enforcement)
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