Recall archive
453 recalls · page 18 of 19
Reported Mar 12, 2014
Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in…
FDA (openFDA device enforcement)
Reported Mar 5, 2014
Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtronic Vascular
Matched: Brand · Product · Product details — Incorrect master label.
FDA (openFDA device enforcement)
Reported Feb 26, 2014
Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models…
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 all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 19, 2014
Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Product · Product details — Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm.
FDA (openFDA device enforcement)
Reported Feb 12, 2014
Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Advanced Energy, LLC
Matched: Brand · Product · Product details — The internal protection circuitry on the electrosurgical output that prevents a patient from exposure to DC voltage when the device is activated is…
FDA (openFDA device enforcement)
Reported Feb 12, 2014
Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Cardiovascular Surgery-the Heart Valve Division
Matched: Brand · Reason for recall — Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with the Mosaic Porcine Aortic Bioprosthesis, Model Number…
FDA (openFDA device enforcement)
Reported Feb 5, 2014
SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic…
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 4, 2013
CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
Matched: Brand · Reason for recall — Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2013
Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular
Matched: Brand · Product details — Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
7 more products in this recall
FDA (openFDA device enforcement)
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)
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