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SUP VERITAS woven self-expanding Nitinol stent system
Merlin @ home transmitter
MitraClip mitral valve repair system
NM implantable pulse generators (IPGs) in Proclaim- and Infinity family
Optisure Defibrillation with dubbel coil
Pacemaker Accent DR and Accent SR
Portico Re-Sheathable Transcatheter Aortic Valve System
Remote Monitoring RF transmitter model EX1150
Eon wall charger and Eon portable charger
Eon, Eon Mini and Brio
Excelis, Fortify, Fortify Assura, HeartMinder, Quadra Assura, Quadra Assura MP, Unify, Unify Assu...
Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra
HeartMate 3 Left Ventricular Assist System (LVAS)
HeartMate II
HeartMate II LVAS Implant sealed with graft HeartMate II system controller and HeartMate II LVAS ...
HeartMate3 Left Ventricular Assist System (LVAS)
Merlin @ home RF transmitter for remotely monitoring
Device Recall Optisure HV lead
  • Model / Serial
    BRE010002 BRE010016 BRE010032 BRE010033 BRE010034 BRE010035 BRE010037 BRE010039 BRE010040 BRE010042 BRE010044 BRE010046 BRE010062 BRE010066 BRE010075 BRE010077 BRE010082 BRE010096 BRE010097 BRE010098 BRE010099 BRE010165 BRE010166 BRE010173 BRE010183 BRE010185 BRE010191 BRE010194 BRE010195 BRE010205 BRE010208 BRE010215 BRE010220 BRE010226 BRE010232 BRE010235 BRE010240 BRE010241 BRE010258 BRE010299 BRE013300 BRE013302 BRG010102 BRG010103 BRG010116 BRG010174 BRG010178 BRG010179 BRG010188 BRG010205 BRG010206 BRG010207 BRG010213 BRG010232 BRG010233 BRG010237 BRG010238 BRG010246 BRG010247 BRG010248 BRG010249 BRG010250 BRG010264 BRG010285 BRG010298 BRG010350 BRG010383 BRG010396 BRG010404 BRG010405 BRG010411 BRG010415 BRG010574 BRG010619 BRG010625 BRG010658 BRG010664 BRG010684 BRG010721 BRG010722 BRG010723 BRG010770 BRG010812 BRG010814 BRG010818 BRG010820 BRG010821 BRG010822 BRG010937 BRG010938 BRG010939 BRG010946 BRG010947 BRG010967 BRG010978 BRG010979 BRG010982 BRG010983 BRG010992 BRG010993 BRG010998 BRG010999 BRG011013 BRG011016 BRG011057 BRG011085 BRG011300 BRG011301 BRG011302 BRG011306 BRG011307 BRG011318 BRG011326 BRG011512 BRH010166 BRH010167 BRH010168 BRH010174 BRH010175 BRH010187 BRH010190 BRH010197 BRH010198 BRH010307 BRH010310 BRH010348 BRH010352 BRH010361 BRH010373 BRH010387 BRH010391 BRH010401 BRH010402 BRH010421 BRH010428 BRH010439 BRH010442 BRH010445 BRH010454 BRH010455 BRH010497 BRH010518 BRH010519 BRH010522 BRH010523 BRH010538 BRH010549 BRH010550 BRH010574 BRH010603 BRH010607 BRH010644 BRH010645 BRH010658 BRH010711 BRH010794 BRH010801 BRH010802 BRH010823 BRH010834 BRH010849 BRH010863 BRH010866 BRH010871 BRH010872 BRH010873 BRH010881 BRH010886 BRH010887 BRH010893 BRH010905 BRH010906 BRH010916 BRH010917 BRH010927 BRH010931 BRH010963 BRH010964 BRH010970 BRH010972 BRH010980 BRH010982 BRH011002 BRH011003 BRH011004 BRH011005 BRH011015 BRH011016 BRH011018 BRH011019 BRH011021 BRH011023 BRH011024 BRH011025 BRH011058 BRH011059 BRH011060 BRH011061 BRH011067 BRH011069 BRH011071 BRH011078 BRH011093 BRH011094 BRH011095 BRH011096 BRH011100 BRH011110 BRH011113 BRH011126 BRH011127 BRH011128 BRH011129 BRH011133 BRH011146 BRH011147 BRM010031 BRM010034 BRM010036 BRM010037 BRM010047 BRM010050 BRM010051 BRM010055 BRM010062 BRM010065 BRM010067 BRM010076 BRM010086 BRM010099 BRM010282 BRM010283 BRM010285 BRM010286 BRM010288 BRM010291 BRM010306 BRM010309 BRM010314 BRM010316 BRM010318 BRM010320 BRM010322 BRM010326 BRM010335 BRM010336 BRM010339 BRM010340 BRM010345 BRM010346 BRM010352 BRM010354 BRM010355 BRM010357 BRM010363 BRM010364 BRM010367 BRM010368 BRM010369 BRM010371 BRM010375 BRM010380 BRM010381 BRM010382 BRM010383 BRM010384 BRM010385 BRR010065 BRR010093 BRR010116 BRR010120 BRR010121 BRR010340 BRR010344 BRR010347 BRR010353 BRR010354 BRR010355 BRR010356 BRR010357 CXM100037 BRE010159 BRE010286 BRE010288 BRG010029 BRG010030 BRG010036 BRG010037 BRG010041 BRG010042 BRG010044 BRG010049 BRG010050 BRG010051 BRG010060 BRG010067 BRG010068 BRG010069 BRG010070 BRG010077 BRG010082 BRG010087 BRG010088 BRG010105 BRG010133 BRG010161 BRG010162 BRG010164 BRG010166 BRG010177 BRG010181 BRG010220 BRG010231 BRG010300 BRG010302 BRG010303 BRG010311 BRG010316 BRG010317 BRG010335 BRG010340 BRG010372 BRG010374 BRG010375 BRG010407 BRG010421 BRG010423 BRG010436 BRG010437 BRG010438 BRG010456 BRG010462 BRG010492 BRG010493 BRG010494 BRG010499 BRG010502 BRG010536 BRG010539 BRG010610 BRG010615 BRG010624 BRG010644 BRG010646 BRG010648 BRG010654 BRG010659 BRG010669 BRG010674 BRG010676 BRG010679 BRG010686 BRG010687 BRG010691 BRG010693 BRG010706 BRG010707 BRG010754 BRG011022 BRG011109 BRG011116 BRG011124 BRG011141 BRG011149 BRG011150 BRG011156 BRG011157 BRG011158 BRG011160 BRG011161 BRG011172 BRG011182 BRG011198 BRG011199 BRG011478 BRH010161 BRH010172 BRH010173 BRH010184 BRH010226 BRH010232 BRH010241 BRH010242 BRH010270 BRH010282 BRH010283 BRH010288 BRH010306 BRH010336 BRH010382 BRH010429 BRH010438 BRH010444 BRH010446 BRH010500 BRH010521 BRH010543 BRH010566 BRH010568 BRH010581 BRH010585 BRH010600 BRH010602 BRH010614 BRH010622 BRH010624 BRH010625 BRH010626 BRH010627 BRH010631 BRH010632 BRH010634 BRH010646 BRH010647 BRH010665 BRH010666 BRH010667 BRH010686 BRH010764 BRH010766 BRH010767 BRH010921 BRH011458 BRH011459 BRH011460 BRH011474 BRH011475 BRH011476 BRH011487 BRH011498 BRH011502 BRH011503 BRH011505 BRH011512 BRH011518 BRH011523 BRH011525 BRH011546 BRH011547 BRH011549 BRH011642 BRH011652 BRL010010 BRP010075 BRP010076 BRP010077 BRP010125
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (nationwide), Belgium, Switzerland, Germany, France, United Kingdom, India, Italy, Japan, Luxembourg, The Netherlands, Saudi Arabia, and Sweden.
  • Product Description
    Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
  • Manufacturer
    St Jude Medical Cardiac Rhythm Management Division
  • 1 Event
Device Recall MitraClip Clip Delivery System
  • Model / Serial
    Lot number  50811U1 50811U2 50812U1 50813U1 50814U1 50826U1 50826U2 50827U1 50908U1 50908U2 50909U1 50910U1 50910U2 50911U1 50924U1 50925U1 50928U1 50929U1 51010U1 51012U1 51012U2 51013U1 51014U1 51014U2 51026U1 51027U3 51028U1 51028U2 51029U1 51030U1 51105U1 51106U1 51109U1 51109U2 51110U1 51110U2 51117U1 51203U1 51204U1 51205U1 51207U1
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Argentina Luxembourg Australia Malaysia Austria Mexico Belgium Netherlands Brazil New Zealand Canada Norway Colombia Philippines Corrientes Poland Czech Republic Portugal Denmark Egypt Romania Finland Saudi Arabia France Slovenia Germany Spain Greece Sweden Hong Kong Switzerland Hungary Thailand Indonesia Turkey Israel United Arab Emirates Italy United Kingdom Kuwait and Vietnam.
  • Product Description
    MitraClip Clip Delivery System, product number MSK0101. The MitraClip System || contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. || The MitraClip Clip Delivery System (CDS) consists of three major components: 1) the Delivery Catheter 2) the Steerable Sleeve, and 3) the MitraClip device. The implantable MitraClip device is located at the distal end of the CDS. The CDS is used to advance and manipulate the implantable MitraClip device for proper positioning and placement on the mitral valve leaflets. The Delivery Catheter, which is part of the CDS, is designed to deliver and deploy the MitraClip. The Delivery Catheter extends through the thru-lumen of the Steerable Sleeve.
  • Manufacturer
    Abbott Vascular
  • 1 Event
Device Recall Ellipse
  • Model / Serial
    Serial No. 7263877 7263892 7263900 7263904 7264199 7265399 7265400 7265401 7263916 7264214 7264398 7265581
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of CT, NJ, SC, FL, GA and countries of: Finland, France, Germany, Great Britain, Greece, Israel, Italy, Japan, Kuwait, Lebanon, Netherlands, Northern Ireland, Poland, Romania, Slovakia, Spain, Tunis, United Arab Emirates, and Vietnam.
  • Product Description
    Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C || Product Usage: || Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
  • Manufacturer
    St Jude Medical Inc.
  • 1 Event
Device Recall HeartMate II Left Ventricular Assist System (LVAS) with Pocket Controller
  • Model / Serial
    All Serial numbers.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.
  • Product Description
    HeartMate¿ II LVAS with Pocket Controller; || 107801 - HMII PUMP & POCKET CTRL ONLY || UDI:00813024011286 || Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
  • Manufacturer
    Thoratec Corporation
  • 1 Event
Device Recall HeartMate II Left Ventricular Assist System (LVAS) with Pocket Controller
  • Model / Serial
    Serial numbers PC-14810, PC-14828, PC-14843, PC-14846, and PC-14848.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.
  • Product Description
    HeartMate¿ II LVAS with Pocket Controller; || 106015 - HMII LVAD SEALED KIT-PCTRL, NA || UDI: 00813024011224 || Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
  • Manufacturer
    Thoratec Corporation
  • 1 Event
Device Recall HeartMate II Left Ventricular Assist System (LVAS) with Pocket Controller
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.
  • Product Description
    HeartMate¿ II LVAS with Pocket Controller; || 106762 - HMII POCKET CONTROLLER, NA; || UDI: 00813024011286 || Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
  • Manufacturer
    Thoratec Corporation
  • 1 Event
Device Recall Proclaim Elite SCS IPG
  • Model / Serial
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO || Product Usage: || The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.
  • Manufacturer
    St. Jude Medical, Inc.
  • 2 Events
Device Recall Merlinhome RF Remote Monitoring Transmitter, Model EX1150, with software versions ...