Recall archive
444 recalls · page 16 of 19
Reported Oct 14, 2015
Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc. Cardiac Rhythm Disease Management
Matched: Brand · Product · Product details — Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional…
FDA (openFDA device enforcement)
Reported Oct 7, 2015
Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Arrow International Inc.
Matched: Product · Product details — Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that…
FDA (openFDA device enforcement)
Reported Oct 7, 2015
P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN; P/N: 9735025,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product details — Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2015
Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc. Cardiac Rhythm Disease Management
Matched: Brand · Product · Product details — An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.
FDA (openFDA device enforcement)
Reported Sep 16, 2015
MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Reason for recall — Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2015
Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed Inc.
Matched: Brand · Reason for recall — Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts…
FDA (openFDA device enforcement)
Reported Aug 26, 2015
Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.
FDA (openFDA device enforcement)
Reported Aug 12, 2015
EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Cardiovascular Surgery-the Heart Valve Division
Matched: Brand · Product details · Reason for recall — Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.
FDA (openFDA device enforcement)
Reported Aug 12, 2015
Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided Passive Biopsy…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere assembly to move on the needle shaft.…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 5, 2015
MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed Inc.
Matched: Brand · Reason for recall — Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not…
FDA (openFDA device enforcement)
Reported Jul 15, 2015
Breast Pack - contains Devon Light Glove Used during surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stradis Healthcare, LLC.
Matched: Reason for recall — Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
50 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2015
Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details · Reason for recall — Medtronic Navigation is initiating a field correction due to the potential for injury which could occur as a result of cleaning the Medtronic…
FDA (openFDA device enforcement)
Reported Jul 8, 2015
Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details · Reason for recall — Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports in which the user had difficulty or was unable to…
FDA (openFDA device enforcement)
Reported Jul 1, 2015
Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
Matched: Product · Product details · Reason for recall — Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or holes
FDA (openFDA device enforcement)
Reported Jun 24, 2015
Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip.
FDA (openFDA device enforcement)
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)
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