FDAFDA · Food and drugs·Recall number Z-2572-2014
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
Published September 10, 2014 · Recall initiated: August 19, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damage to the high voltage capacitors, which may result in extended charge time, occurring during capacitor maintenance or charging for high voltage therapy. It may present as a vibratory patient notification and upon interrogation, a programmer or Merlin.net alert.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- St Jude Medical Cardiac Rhythm Management Division
- Distributor
- Worldwide Distribution: US (nationwide), Canada, Australia, New Zealand, Japan, EU, Middle East, Latin America, and Asia-Pacific.
- Lot
- Serial Numbers: 1004962 1004963 1004964 1004965 1004966 1004967 1004968 1004969 1004970 1004971 1004972 1004973 1004974 1004975 1004976 1004977 1004978 1004979 1004980 1004981 1004982 1004983 1004984 1004985 1004986 1004987 1004988 1004989 1004990 1004991 1004992 1004993 1004994 1004995 1004996 1004997 1004998 1004999 1005000 1005001 1005002 1005003 1005004 1005005 1005006 1005007 1005008 1005009 1005010 1005011 1005139 1005140 1005141 1005142 1005143 1005144 1005145 1005146 1005147 1005148 1005149 1005150 1005151 1005152 1005153 1005154 1005155 1005156 1005157 1005158 1005159 1005160 1005161 1005162 1005163 1005164 1005165 1005166 1005167 1005168 1005169 1005170 1005171 1005172 1005173 1005174 1005175 1005176 1005177 1005178 1005179 1005180 1005181 1005182 1005183 1005184 1005185 1005186 1005187 1005188 1005311 1005312 1005313 1005314 1005315 1005316 1005317 1005318 1005319 1005320 1005321 1005322 1005323 1005324 1005325 1005326 1005327 1005328 1005329 1005330 1005331 1005332 1005333 1005334 1005335 1005336 1005337 1005338 1005339 1005340 1005341 1005342 1005343 1005344 1005345 1005346 1005347 1005348 1005349 1005350 1005351 1005352 1005353 1005354 1005355 1005356 1005357 1005358 1005359 1005360 1005734 1005735 1005736 1005737 1005739 1005740 1005741 1005742 1005743 1005744 1005745 1005746 1005747 1005748 1005749 1005750 1005751 1005752 1005753 1005754 1005755 1005756 1005757 1005758 1005759 1005761 1005762 1005763 1005764 1005766 1005767 1005768 1005769 1005770 1005771 1005772 1005773 1005774 1005775 1005776 1005777 1005778 1005779 1005780 1005781 1005782 1005783 1005784 1005785 1005786 1005787 1005788 1005790 1005791 1005792 1005793 1006090 1006091 1006092 1006093 1006094 1006095 1006096 1006097 1006098 1006099 1006100 1006101 1006102 1006103 1006104 1006105 1006106 1006107 1006108 1006109 1006110 1006111 1006112 1006113 1006114 1006115 1006116 1006117 1006118 1006119 1006120 1006121 1006122 1006123 1006124 1006125 1006126 1006127 1006128 1006129 1006130 1006131 1006132 1006133 1006134 1006135 1006136 1006137 1006138 1006139 1006140 1006141 1006142 1006143 1006144 1006145 1006146 1006147 1006148 1006149 1006150 1006151 1006152 1006153 1006154 1006155 1006156 1006157 1006158 1006159 1006160 1006161 1006162 1006163 1006164 1006165 1006166 1006167 1006168 1006169 1006170 1006171 1006172 1006173 1006174 1006175 1006176 1006177 1006178 1006179 1006512 1006513 1006514 1006515 1006516 1006517 1006518 1006519 1006520 1006521 1006522 1006523 1006524 1006525 1006526 1006527 1006528 1006529 1006530 1006531 1006532 1006533 1006534 1006535 1006536 1006538 1006539 1006540 1006541 1006542 1006543 1006544 1006545 1006546 1006547 1006548 1006549 1006550 1006551 1006552 1006553 1006554 1006555 1006556 1006557 1006558 1006559 1006560 1006561 1006562 1006563 1006564 1006565 1006566 1006567 1006568 1006569 1006570 1006571 1006572 1006573 1006574 1006575 1006576 1006577 1006578 1006579 1006580 1006581 1006582 1006583 1006584 1006585 1006586 1006587 1006588 1006589 1006590 1006591 1006592 1006593 1006594 1006595 1006596 1006597 1007390 1007391 1007392 1007393 1007394 1007395 1007396 1007397 1007398 1007399 1007400 1007401 1007402 1007403 1007404 1007405 1007406 1007407 1007408 1007409 1007410 1007411 1007412 1007413 1007414 1007415 1007416 1007417 1007418 1007419 1007420 1007421 1007422 1007423 1007424 1007425 1007426 1007427 1007428 1007429 1007430 1007431 1007432 1007433 1007434 1007435 1007436 1007437 1007438 1007439 1007440 1007441 1007442 1007443 1007444 1007445 1007446 1007447 1007448 1007449 1007450 10074
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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