Class 1 Device Recall LifeSPARC Controller

• Date Initiated by Firm: December 05, 2022
• Date Posted: January 19, 2023
• Recall Status: Terminated on August 08, 2023
• Recall Number: Z-0926-2023
• Recall Event ID: 91362
• 510(K)Number: K183623
• Product Classification: Control, pump speed, cardiopulmonary bypass - Product Code DWA
• Product: SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
• Code Information: Model No. 5900-0000 - UDI/DI 00814112020562 Model No. 5900-0001 - UDI/DI 00814112020623 Serial Numbers C00115 C50232 C50253 C50403 C00195 C50619 C50623 C50161 C50167 C50362 C50388 C50432 C50505 C00189 C50648 C50437 C50671 C50690 C00048 C00087 C50114 C50135 C00149 C50274 C50506 C50308 C50319 C00040 C00107 C50207 C50160 C50016 C50604 C50493 C50355 C50633 C00126 C00155 C50113 C00041 C00135 C00042 C00035 C50012 C50019 C50073 C00176 C50386 C50677 C00052 C00076 C00092 C50384 C50490 C50679 C00095 C50149 C00182 C50392 C50337 C50451 C50708 C50306 C50460 C50512 C50082 C50174 C00151 C50328 C50111 C50501 C00157 C50363 C50476 C50701 C50212 C50219 C50350 C00174 C00006 C50076 C50105 C50235 C50613 C50197 C50375 C50463 C50517 C50632 C50653 C50662 C00199 C00205 C50699 C50269 C50398 C50618 C50606 C50645 C50100 C50101 C50626 C50204 C50266 C50330 C50031 C50050 C50241 C50524 C00188 C00197 C50131 C50181 C50365 C00038 C50237 C00190 C50598 C50283 C00143 C50287 C50288 C50259 C50270 C00185 C50202 C00209 C50639 C00158 C50357 C50601 C50289 C50592 C50640 C50059 C50065 C50097 C50043 C50037 C50072 C50096 C50153 C50140 C50703 C50391 C50642 C50536 C50682 C50314 C50354 C50470 C50409 C50526 C50146 C50225 C50226 C50001 C50090 C00169 C00023 C00161 C50224 C50458 C50525 C50581 C50591 C50428 C50466 C00202 C00196 C50593 C50539 C50303 C00127 C00063 C50211 C50229 C50280 C00167 C50374 C50387 C00141 C00136 C00145 C50312 C00073 C50243 C00150 C50222 C50343 C50425 C00053 C00057 C50652 C00113 C00114 C50038 C50247 C50651 C50654 C00203 C50521 C50689 C00072 C50208 C50485 C50492 C50057 C50126 C00152 C00094 C50389 C50399 C50453 C50148 C50168 C00148 C50456 C50015 C00098 C50465 C50448 C50406 C50026 C50044 C50162 C00016 C50056 C50170 C00031 C50042 C50058 C50469 C00039 C00078 C00093 C00089 C50157 C50234 C50236 C50426 C50318 C50395 C00166 C50327 C50356 C50410 C50471 C50262 C50385 C50195 C50196 C00132 C00130 C50381 C50436 C50435 C50047 C50055 C50064 C50429 C50688 C50370 C50377 C00198 C50486 C50627 C50664 C50066 C50078 C50468 C50093 C50186 C50614 C50216 C50534 C50610 C50077 C50108 C00180 C50414 C00079 C00172 C50248 C50257 C00083 C50041 C50364 C50452 C50706 C50707 C50530 C50074 C50479 C50575 C00201 C50046 C50326 C50498 C50675 C50430 C50438 C50607 C50018 C50175 C50014 C00144 C50477 C50267 C50119 C50024 C50185 C50256 C50290 C00165 C50400 C50508 C00015 C00044 C00045 C50344 C50631 C50649 C50635 C50251 C50503 C50084 C50122 C50130 C50115 C50228 C00184 C50507 C50087 C50532 C50104 c50182 C50198 C50531 C00051 C50051 C50123 C50294 C50444 C50600 C50271 C50272 C50296 C50313 C50279 C50443 C50515 C00138 C50194 C00054 C00081 C50624 C50630 C00171 C50376 C50434 C50457 C00175 C50599 C50263 C50497 C50496 C50494 C50322 C50411 C50107 C00146 C50329 C50609 C50666 C50697 C50176 C50307 C00194 C50171 C50459 C50616 C50636 C50647 C50023 C50034 C50423 C50298 C50348 C50215 C50351 C50667 C50663 C50641 C50120 C50109 C50537 C50404 C50145 C50514 C00109 C50035 C50010 C50080 C50393 C50397 C50462 C50617 C50668 C50656 C50439 C50449 C50670 C50638 C50588 C50683 C50334 C50052 C50062 C50190 C50300 C00163 C00164 C00043 C00082 C50680 C50033 C50475 C50249 C00080 C50070 C50704 C50698 C50003 C50004 C50128 C50020 C50191 C50187 C50405 C50422 C50371 C50511 C50672 C50116 C50184 C50305 C50366 C50143 C50154 C50060 C50063 C50299 C50379 C50488 C50331 C00183 C50136 C50139 C50177 C50141 C00178 C50582 C00088 C50025 C50193 C50495 C50007 C50110 C50164 C00168 C00050 C50221 C50489 C50596 C00206 C50685 C50584 C50673 C50324 C50345 C50006 C50048 C50036 C50068 C50401 C50320 C50472 C50474 C50205 C50323 C50440 C50629 C50579 C50646 C50661 C50589 C50578 C50491 C50192 C50220 C50252 C50340 C50402 C00066 C50481 C50029 C50217 C50233 C50467 C00049 C00062 C00200 C00204 C00034 C50255 C50342 C50309 C50361 C50333 C50499 C50081 C50049 C50103 C50346 C50347 C50519 C50152 C50297 C50369 C50373 C50695 C50189 C50292 C00037 C00110 C50316 C50528 C50620 C00160 C50595 C50594 C50311 C50304 C50121 C50454 C50239 C50282 C50416 C50621 C50504 C50441 C50587 C00154 C50227 C50368 C50478 C00170 C00173 C50339 C00153 C00159 C50264 C50396 C00055 C00105 C50284 C50605 C50293 C50291 C50684 C50132 C50583 C50231 C50240 C50461 C50352 C50383 C50527 C00112 C50028 C50013 C50159 C50455 C50275 C50295 C00074 C50201 C00208
• Recalling Firm/ Manufacturer: Cardiac Assist, Inc; 240 Alpha Dr; Pittsburgh PA 15238-2906
• For Additional Information Contact: Deanna Wilke; 281-228-7434 Ext. 227
• Manufacturer Reason for Recall: A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data.
• FDA Determined Cause: Software design
• Action: On December 5, 2022, the firm notified customers through Urgent Medical Device Communication letters that a software update has been developed to address the issue of Critical Failure. The only action required by the customer will be to make their equipment available for the third-party representative from MERA to perform the update and sign off on the form once the upgrade is completed. This software update is the follow-up to the earlier recall notification on or around July 21, 2022, when customers were instructed to use a new revision of the Operations Manual. For questions regarding this Medical Device Removal, please contact your LivaNova representative, or LivaNova Customer Quality at LivaNova.FSCA@livanova.com.
• Quantity in Commerce: 763 (US only)
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DWA