Recall archive
453 recalls · page 13 of 19
Reported Feb 14, 2018
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB)…
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 custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
FDA (openFDA device enforcement)
Reported Jan 31, 2018
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure
Matched: Brand · Product · Product details · Reason for recall — Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2018
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Product · Product details · Reason for recall — Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal…
FDA (openFDA device enforcement)
Reported Dec 6, 2017
Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Stent length on the label may not match the length of the stent itself.
FDA (openFDA device enforcement)
Reported Nov 29, 2017
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details · Reason for recall — Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 25, 2017
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.
FDA (openFDA device enforcement)
Reported Oct 4, 2017
Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product · Product details — It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two…
FDA (openFDA device enforcement)
Reported Sep 27, 2017
Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 27, 2017
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular Galway dba Medtronic Ireland
Matched: Brand — Stylette removal difficulties on the Euphora and Solarice products.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 30, 2017
Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 30, 2017
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which can result in DBS lead placement beyond the intended…
FDA (openFDA device enforcement)
Reported Aug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Reason for recall — Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes…
15 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 2, 2017
Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um…
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 has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around…
FDA (openFDA device enforcement)
Reported Aug 2, 2017
DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 26, 2017
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version…
FDA (openFDA device enforcement)
Reported Jun 28, 2017
MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Reason for recall — Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 21, 2017
Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic
Matched: Brand — Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 14, 2017
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument.…
FDA (openFDA device enforcement)
Reported May 31, 2017
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure
Matched: Brand · Reason for recall — An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad…
FDA (openFDA device enforcement)
Reported May 17, 2017
Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Product · Product details — Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one…
FDA (openFDA device enforcement)
Reported May 10, 2017
BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Product · Product details — Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was…
FDA (openFDA device enforcement)
Reported May 10, 2017
MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Reason for recall — Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. When the software anomaly occurs it…
FDA (openFDA device enforcement)
Reported May 10, 2017
Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Newport Medical Instruments Inc.
Matched: Reason for recall — Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown…
FDA (openFDA device enforcement)
Reported Apr 26, 2017
Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien Medtronic
Matched: Brand — Customer reports of the device handset continuing to operate after release of the activation button.
FDA (openFDA device enforcement)
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