Recall archive
453 recalls · page 16 of 19
Reported Mar 9, 2016
Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtronic Perfusion Systems
Matched: Brand · Product · Product details · Reason for recall — Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected…
FDA (openFDA device enforcement)
Reported Mar 2, 2016
Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening…
FDA (openFDA device enforcement)
Reported Feb 24, 2016
Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic
Matched: Brand — Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 23, 2015
MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed Inc.
Matched: Brand — The pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 9, 2015
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details · Reason for recall — Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high…
FDA (openFDA device enforcement)
Reported Dec 2, 2015
Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA, Inc. - Dallas Distribution
Matched: Brand — The wire pass hole is not present on the tools.
FDA (openFDA device enforcement)
Reported Nov 18, 2015
Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is…
FDA (openFDA device enforcement)
Reported Nov 18, 2015
Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Reason for recall — Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the…
FDA (openFDA device enforcement)
Reported Nov 11, 2015
Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — 64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
FDA (openFDA device enforcement)
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)
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