Recall archive
444 recalls · page 11 of 19
Reported Feb 27, 2019
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
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 · Reason for recall — There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic…
FDA (openFDA device enforcement)
Reported Feb 20, 2019
Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details · Reason for recall — A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 13, 2019
MEDTRONIC CARELINK 2090 programmer
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 is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 6, 2019
RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Reason for recall — Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 9, 2019
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand · Product details — An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of…
FDA (openFDA device enforcement)
Reported Jan 2, 2019
Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens.…
FDA (openFDA device enforcement)
Reported Dec 19, 2018
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heartware, Inc.
Matched: Product · Product details — HVAD Battery Charger units manufactured with wrong inductors.
FDA (openFDA device enforcement)
Reported Nov 21, 2018
Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Reason for recall — The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal…
FDA (openFDA device enforcement)
Reported Nov 21, 2018
INFUSE Bone Graft X SMALL KIT REF 7510100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
FDA (openFDA device enforcement)
Reported Nov 14, 2018
Medtronic CareLink 2090 Programmer
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 · Reason for recall — Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 14, 2018
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand · Product · Product details — O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label;…
FDA (openFDA device enforcement)
Reported Oct 31, 2018
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand — Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 3, 2018
Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Reason for recall — Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in…
FDA (openFDA device enforcement)
Reported Oct 3, 2018
Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
Matched: Brand · Product · Product details — The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the…
FDA (openFDA device enforcement)
Reported Oct 3, 2018
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtronic Vascular
Matched: Brand · Product · Product details · Reason for recall — Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French…
FDA (openFDA device enforcement)
Reported Sep 26, 2018
Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and distributed. This meter contains the incorrect unit of…
FDA (openFDA device enforcement)
Reported Aug 15, 2018
Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Product · Product details — This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on…
FDA (openFDA device enforcement)
Reported Jul 25, 2018
Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien Medtronic
Matched: Brand — Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line…
13 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 25, 2018
Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Reason for recall — Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fibers were not tested at intended laser power levels,…
FDA (openFDA device enforcement)
Reported Jul 25, 2018
Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product details — This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit, to have a potential manufacturing…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 18, 2018
Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand — Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 11, 2018
Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — The MiniMed Paradigm Veo insulin pump has an error that impacts the Arabic language translation.This translation error occurs in the Predictive…
FDA (openFDA device enforcement)
Reported Jul 4, 2018
Single Chamber Temporary External Pacemaker, Model 53401
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 — A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use…
FDA (openFDA device enforcement)
Reported Jun 6, 2018
Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Heartware
Matched: Product · Product details — Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller,…
FDA (openFDA device enforcement)
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