Recall archive
444 recalls · page 18 of 19
Reported Nov 20, 2013
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions:…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2013
Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product details — A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Coronary Sten System may contain a compliance chart…
FDA (openFDA device enforcement)
Reported Nov 6, 2013
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2013
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand — Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
FDA (openFDA device enforcement)
Reported Oct 9, 2013
NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product · Product details — Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the size of the device as 2.5mm instead of the correct…
FDA (openFDA device enforcement)
Reported Oct 2, 2013
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand — One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
FDA (openFDA device enforcement)
Reported Sep 25, 2013
T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD…
FDA (openFDA device enforcement)
Reported Sep 4, 2013
Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc. Cardiac Rhythm Disease Management
Matched: Brand · Product · Product details · Reason for recall — Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 28, 2013
Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed
Matched: Brand · Product · Product details · Reason for recall — Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm…
FDA (openFDA device enforcement)
Reported Aug 21, 2013
Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall Update…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc. Cardiac Rhythm Disease Management
Matched: Brand · Product · Product details · Reason for recall — Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small…
FDA (openFDA device enforcement)
Reported Aug 21, 2013
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Reason for recall — Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation…
FDA (openFDA device enforcement)
Reported Aug 21, 2013
Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand — The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain…
FDA (openFDA device enforcement)
Reported Aug 14, 2013
Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into 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 · Reason for recall — Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages…
FDA (openFDA device enforcement)
Reported Jul 31, 2013
Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
Matched: Brand · Product · Product details · Reason for recall — Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer carton had expiration dates that were incorrect. The…
FDA (openFDA device enforcement)
Reported Jul 17, 2013
Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic MiniMed
Matched: Brand · Product · Product details · Reason for recall — Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a…
FDA (openFDA device enforcement)
Reported Jul 3, 2013
Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc. Cardiac Rhythm Disease Management
Matched: Brand · Product · Product details · Reason for recall — Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2013
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2013
INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Product · Product details — Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2013
lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Invatec LLC
Matched: Product details — Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.
FDA (openFDA device enforcement)
Reported Jun 12, 2013
REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Xomed, Inc.
Matched: Brand · Product · Product details · Reason for recall — In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which…
FDA (openFDA device enforcement)
Reported Jun 5, 2013
adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.TZ Medical Inc.
Matched: Reason for recall — TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may…
FDA (openFDA device enforcement)
Reported May 22, 2013
PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConMed Corporation
Matched: Product details — ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or…
FDA (openFDA device enforcement)
Reported May 8, 2013
Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 17, 2013
Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed
Matched: Brand · Product · Product details · Reason for recall — Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap may become detached from the pump case and protrude…
FDA (openFDA device enforcement)
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