FDAFDA · Food and drugs·Recall number Z-2511-2020
Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
Published July 15, 2020 · Recall initiated: June 4, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Distributor
- worldwide
- Lot
- a) W1TR01, serial numbers: RNO200006H RNO200023H RNO200029H RNO200036H RNO200038H RNO200041H RNO200044H RNO200048H RNO200050H RNO200051H RNO200064H RNO200070H RNO200086H RNO200088H RNO200096H RNO200105H RNO200109H RNO200110H RNO200136H RNO200140H RNO200012H RNO200013H RNO200025H RNO200030H RNO200031H RNO200034H RNO200035H RNO200037H RNO200043H RNO200046H RNO200047H RNO200054H RNO200055H RNO200056H RNO200058H RNO200060H RNO200061H RNO200065H RNO200067H RNO200068H RNO200069H RNO200071H RNO200072H RNO200074H RNO200075H RNO200076H RNO200078H RNO200079H RNO200081H RNO200082H RNO200084H RNO200085H RNO200087H RNO200091H RNO200093H RNO200098H RNO200099H RNO200101H RNO200111H RNO200112H RNO200115H RNO200116H RNO200118H RNO200121H RNO200122H RNO200125H RNO200127H RNO200128H RNO200129H RNO200131H RNO200132H RNO200133H RNO200134H RNO200137H RNO200138H RNO200141H RNO200143H RNO200144H RNO200145H RNO200027H RNO200100H RNO200106H RNO200151H RNO200155H RNO200162H RNO200103H RNO200165H RNO200166H RNO200167H RNO200168H RNO200169H RNO200171H RNO200173H RNO200174H RNO200175H RNO200178H RNO200179H RNO200180H RNO200181H RNO200182H RNO200183H RNO200184H RNO200185H RNO200186H RNO200187H RNO200188H RNO200189H RNO200190H RNO200192H RNO200193H RNO200194H RNO200040H RNO200102H RNO200146H RNO200148H RNO200150H RNO200157H RNO200158H RNO200159H RNO200161H RNO200163H RNO200164H RNO200172H RNO200059H RNO200080H RNO200160H RNO200196H RNO200197H RNO200198H RNO200199H RNO200200H RNO200201H RNO200203H RNO200204H RNO200205H RNO200206H RNO200207H RNO200208H RNO200209H RNO200210H RNO200211H RNO200212H RNO200213H RNO200215H RNO200216H RNO200218H RNO200220H RNO200222H RNO200223H RNO200224H RNO200225H RNO200228H RNO200229H RNO200230H RNO200231H RNO200233H RNO200235H RNO200236H RNO200239H RNO200240H RNO200241H RNO200242H RNO200243H RNO200245H RNO200246H RNO200247H RNO200248H RNO200250H RNO200252H RNO200253H RNO200254H RNO200255H RNO200256H RNO200257H RNO200258H RNO200259H RNO200260H RNO200261H RNO200262H RNO200263H RNO200266H RNO200268H RNO200269H RNO200270H RNO200271H RNO200272H RNO200274H RNO200276H RNO200279H RNO200280H RNO200281H RNO200282H RNO200284H RNO200286H RNO200287H RNO200288H RNO200291H RNO200293H RNO200294H RNO200295H RNO200297H RNO200298H RNO200299H RNO200300H RNO200301H RNO200303H RNO200305H RNO200309H RNO200310H RNO200311H RNO200313H RNO200314H RNO200315H RNO200316H RNO200318H RNO200319H RNO200320H RNO200321H RNO200323H RNO200324H RNO200275H RNO200290H RNO200292H RNO200296H RNO200053H RNO200077H RNO200277H RNO200307H RNO200325H RNO200326H RNO200327H RNO200330H RNO200331H RNO200335H RNO200336H RNO200342H RNO200343H RNO200344H RNO200349H RNO200351H RNO200353H RNO200356H RNO200357H RNO200358H RNO200359H RNO200363H RNO200369H RNO200371H RNO200373H RNO200380H RNO200381H RNO200382H RNO200383H RNO200384H RNO200332H RNO200346H RNO200368H RNO200339H RNO200348H RNO200352H RNO200354H RNO200355H RNO200361H RNO200367H RNO200414H RNO200416H RNO200418H RNO200420H RNO200425H RNO200430H RNO200434H RNO200441H RNO200413H RNO200415H RNO200419H RNO200421H RNO200422H RNO200423H RNO200426H RNO200427H RNO200428H RNO200429H RNO200431H RNO200432H RNO200435H RNO200436H RNO200437H RNO200439H RNO200440H RNO200273H RNO200333H RNO200334H RNO200265H RNO200350H RNO200375H RNO200377H RNO200379H RNO200389H RNO200459H RNO200472H RNO200478H RNO200479H RNO200484H RNO200485H RNO200496H RNO200502H RNO200504H RNO200505H RNO200507H RNO200509H RNO200510H RNO200511H RNO200518H RNO200519H RNO200525H RNO200529H RNO200531H RNO200532H RNO200533H RNO200534H RNO200010H RNO200386H RNO200387H RNO200388H RNO200391H RNO200393H RNO200394H RNO200395H RNO200396H RNO200397H RNO200401H R
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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