Recall archive
453 recalls · page 17 of 19
Reported Jun 3, 2015
Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm…
FDA (openFDA device enforcement)
Reported May 27, 2015
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This…
FDA (openFDA device enforcement)
Reported Apr 8, 2015
Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc. Cardiac Rhythm Disease Management
Matched: Brand · Product · Product details — Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA (LR6) battery did…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 25, 2015
Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc. Cardiac Rhythm Disease Management
Matched: Brand · Product · Product details — Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients…
FDA (openFDA device enforcement)
Reported Mar 11, 2015
CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtronic MiniMed Inc.
Matched: Brand · Product · Product details — The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink…
FDA (openFDA device enforcement)
Reported Mar 4, 2015
The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter…
FDA (openFDA device enforcement)
Reported Feb 11, 2015
KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or…
FDA (openFDA device enforcement)
Reported Jan 21, 2015
POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Product · Product details — The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining…
FDA (openFDA device enforcement)
Reported Dec 17, 2014
Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed Inc.
Matched: Brand · Product · Product details — Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets. Detachment causes interrupted…
FDA (openFDA device enforcement)
Reported Dec 17, 2014
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Reason for recall — Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to…
FDA (openFDA device enforcement)
Reported Nov 26, 2014
BAG 9732315 MOUSE STERILE 15 PK
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Reason for recall — Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned,…
24 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2014
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular
Matched: Brand · Product · Product details — Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the…
FDA (openFDA device enforcement)
Reported Sep 17, 2014
Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Cardiovascular Surgery-the Heart Valve Division
Matched: Brand · Reason for recall — Medtronic has decided to discontinue production and distribution of this low-volume product.
FDA (openFDA device enforcement)
Reported Sep 3, 2014
Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed Inc.
Matched: Brand · Product · Product details · Reason for recall — Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally…
FDA (openFDA device enforcement)
Reported Aug 27, 2014
Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during…
FDA (openFDA device enforcement)
Reported Aug 20, 2014
Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed Inc.
Matched: Brand · Product · Product details · Reason for recall — Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a pump malfunction resulting in the disconnection of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 20, 2014
Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which are used with the implantable SynchroMed drug…
FDA (openFDA device enforcement)
Reported Aug 6, 2014
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an…
FDA (openFDA device enforcement)
Reported Jul 9, 2014
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neurosurgery
Matched: Brand · Product · Product details · Reason for recall — Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2014
Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is…
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 determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
FDA (openFDA device enforcement)
Reported Jun 4, 2014
Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI).…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc. Cardiac Rhythm Disease Management
Matched: Brand · Product · Product details — Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180…
FDA (openFDA device enforcement)
Reported May 14, 2014
Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 7, 2014
Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 2, 2014
FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in (…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product details · Reason for recall — Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the…
2 more products in this recall
FDA (openFDA device enforcement)
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