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U.S. Department of Health and Human Services

Class 2 Device Recall Fogarty Arterial Embolectomy Catheters and Fogarty Biliary Balloon Probes

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 Class 2 Device Recall Fogarty Arterial Embolectomy Catheters and Fogarty Biliary Balloon Probessee related information
Date Initiated by FirmOctober 06, 2022
Date PostedOctober 28, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0146-2023
Recall Event ID 90905
510(K)NumberK193379 
Product Classification Catheter, embolectomy - Product Code DXE
ProductFogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP
Code Information Fogarty Arterial 120403FP Embolectomy Catheters Model Number / UDI-DI Code: 120602FP / 00690103205206 Lot Numbers: 63325817 63412990 64049166 64052416 64320468 64311217 64286041 64075556 64085285 64124889 64180619 63914203 63967960 63266275 63281593 63449645 63560630 63612077 63626926 63738860 63735762 63750304 63772968 63724845 63914201 63892007 63967950 63990050 64027881 64036551 64052415 64063487 64124888 64173669 64180620 64180548 64332505 64344742 63907174 64099010 64099008 63420190 63435603 63476159 63511721 63600508 63611742 63669399 63750303 63735818 63850952 63907175 63944429 63984736 63944467 63907167 64014108 63995701 64036698 64075555 64180549 64173668 64110676 64205522 64220842 64252735 64231811 64231810 64264792 64274428 64297806 64297810 64321021 64321020 63281591 63375216 63420189 63464807 63501933 63560629 63634785 63612076 63914359 64193163 64266393 64239056 63375217 64059266 64252737 63735761 63412989 63600507 63633312 63990049 64193162 64205539 64383524 64394451 63611743 63352974 63386855 63340743 63349810 63432009 63449644 63476158 63435604 63487678 63464806 63513249 63612073 63612074 63560631 63669400 63612075 63661028 63670579 63670029 63670031 63712780 63687299 63712779 63670028 63776322 63797464 63892006 63850950 63856376 63883760 63883761 63944427 63954394 63990047 63990048 64025093 64063485 64099009 64180550 64383526 64243759 64205521 64273885 64239057 64276520 64252736 64274714 64297805 64264793 64286039 64343086 64354938 64368268 64368267 64085286 64344743 64354939 120403FP / 00690103205084 Lot Numbers: 63281594 63420192 63293457 63292302 63435605 63227617 63266276 63851020 64180623 64063399 64180621 64173655 64349486 64274431 63735809 63600513 63611735 63611730 63612145 63612148 63612150 63750306 63851019 63967943 64049155 64085389 64205542 63412996 63646477 63626918 63851013 64075580 64286055 63449646 63523069 63801880 64220844 63525902 63669388 63243860 63292299 63243604 63508558 63511555 63611731 63600510 63611734 63554739 63600511 63600512 63614211 63612144 63612149 63626919 63724825 63724827 63735752 63735810 63772972 63851016 63851015 63851017 63851018 63883814 63944461 63892043 63914365 63954398 63967944 63967942 63990042 63995709 64037831 64052468 64099018 64099015 64110682 64124920 64180560 64180559 64180622 64205543 64252738 64297812 64311232 64180561 120803FP / 00690103205091 Lot Numbers: 63281615 63301866 63293544 63449651 63281616 63540578 64014116 64036550 64085388 64173662 64180628 64239085 64193189 64228631 64311235 64231815 64063488 64180563 64180627 63670047 63883800 63914374 63892047 63990053 64368271 64349489 63883785 63883787 63998710 64017928 64231982 64193181 64231983 64252743 64297822 63281612 63266279 63304187 63266281 63266282 63386864 63501940 63612157 63661024 63751152 63751153 63751155 63776326 63990044 63990045 64075767 64110680 64311241 63669391 63677169 63670050 63735803 63670049 63851025 63851026 63375226 63266280 63612155 63634613 63626908 63661023 63892046 64052470 64063490 64085387 64110678 64110679 64124922 64124900 64231981 63298984 63239466 63266283 63386863 63386862 63449653 63540575 63566182 63566181 63626907 63661021 63661025 63670042 63990052 64052471 64036700 64049148 64063489 64124899 64075768 64075769 64075770 64165221 64180564 64180626 64286058 64311236 63612159 63525901 63778897 63364602 63386869 63412994 63487681 63501936 63540576 63540577 63600515 63772970 63751167 63724835 63990046 63856382 64231814 63707884 63281611 63281614 63375224 63301865 63325826 63357626 63375222 63375223 63481504 63449650 63386860 63412998 63412997 63412999 63464809 63487680 63239464 63501935 63501937 63501939 63540579 63540581 63540582 63540580 63554746 63549889 63554743 63566180 63600514 63611737 63612154 63612158 63612156 63626909 63669392 63669393 63669394 63670048 63670044 63701954 63670043 63670045 63611736 63670046 63707886 63998713 63707885 63720568 63720569 63735742 63735743 63735744 63776325 63856386 63883799 63883786 63914372 63914209 63944415 63944416 63944413 63944414 63944417 63984731 63954397 63967939 63990043 63998711 63995708 64025077 64025078 64025076 64036699 64052572 64124901 64170458 64165222 64170459 64180562 64180565 64180625 64193185 64193182 64193184 64193183 64220848 64193180 64205551 64205550 64220847 64228630 64239086 64239087 64252742 64287027 64332513 64354942 64368272 64252745 64332514 64394457 64437468 64321034 64332512 120404FP / 00690103205107 Lot Numbers: 63316243 63266182 63412917 63447531 63386786 63431368 63449609 63266183 63464776 64049163 64052436 64193102 64269069 64098037 64297683 64052343 64102638 64075502 64180580 64052438 64180581 64289824 63266184 63776293 63779313 63712318 63744071 63883295 63883298 63891423 63967940 64085229 64098969 63883297 63954328 64036656 64180497 63375235 63266187 63375233 63523032 63669373 63669372 63669375 63669450 63677010 63883293 63954330 63998630 63998649 64075503 63523031 63670567 63850871 63850944 64014032 64098970 63375234 63325721 63325722 63266185 63266186 63386785 63386787 63484847 63611718 63611709 63612665 63633256 63611710 63611717 63613958 63612519 63634526 63670558 63612661 63612662 63612663 63612664 63669374 63797445 63669949 63669950 63687362 63687361 63944457 63735746 63772848 63797446 63850940 63850925 63856326 63891421 63891422 63914292 63944418 63954327 63954329 63996461 63967954 63996462 63996463 64013516 64049149 64110621 64235882 64205453 64220812 64231975 64289816 64289830 64302644 64297076 64285989 64297079 64180496 64332474 64354883 64367857 64367856 64367859 64457671 120804FP / 00690103205213 Lot Numbers: 63349774 63349775 63158527 63449617 63502089 63349776 63412930 63420128 63435526 63707881 64036540 64036679 64049164 64085232 64180590 64173640 64252689 64252690 64274410 64285995 64285992 64320982 64036538 64205460 64311189 64063474 64075525 64085244 64173639 64180587 64180501 64180586 63669378 63944470 63914323 63914324 63998618 63944425 63944464 64027787 64014034 63998619 63776284 63735816 63914300 63995681 64027785 63998650 63316255 63310745 63301457 63316256 63349777 63408651 63340195 63518665 63626923 63633261 63669968 63669974 63735759 63797452 63856327 63883274 63914295 64049158 64052346 64098973 64098974 64180502 64205461 64344512 63681741 63669966 63695259 63633264 63633257 63669965 63720549 63633262 63735757 63797633 63883278 63883275 64014030 64075524 64049160 64049161 64063476 64098975 64110626 64193109 64205459 64252683 64264746 64344515 64264744 63408652 63612523 63316250 63316252 63316254 63612524 64173638 63306291 63306430 63340221 63364540 63349778 63412928 63412929 63518667 63626927 63633265 63677012 63850873 63850946 63856354 63883272 63883273 64140000 64220814 64025086 63316259 63357479 63357475 63357478 63316258 63316257 63325723 63340220 63340230 63349773 63449618 63408657 63375245 63375252 63375251 63386791 63431713 63431711 63487615 63518663 63523057 63502109 63502108 63502106 63600432 63600431 63600433 63600435 63600438 63600436 63600443 63600442 63611720 63611721 63611722 63612529 63626922 63626928 63626924 63626921 63633263 63669377 63669975 63669967 63669970 63735758 63669969 63677011 63707880 63687367 63720548 63779337 63735815 63712338 64036658 63776282 63776283 63776285 63852650 63850868 63797632 63850927 63850941 63856329 63883271 63891431 63913712 63913713 63914296 63914297 63998629 63914298 63954332 63967956 63967987 63967988 63967957 63967989 63998628 63995679 63998627 63998626 63998616 64013533 63998651 64025084 64025087 64036668 64025088 64025089 64025090 64025091 64025092 64036669 64036672 64049159 64075526 64085243 64075527 64110627 64139995 64139999 64173637 64180504 64180503 64180589 64180588 64193110 64193111 64193112 64231977 64231976 64238950 64252684 64252686 64274409 64297687 64311188 64311191 64311190 64285993 64320983 64354894 64393998 64394004 64405975 64405978 120805FP / 00690103205220 Lot Numbers: 63325740 63431899 63412921 63995680 63998608 64014033 64285999 64285997 64231795 64238960 64063482 64098984 64063360 64173647 64231724 64205465 64205464 64052348 64110622 63712340 63852652 63850945 63944419 64344670 63918798 63891430 63984701 63944420 63998640 63995682 63954331 63420141 63292125 63364537 63364539 63386792 63435528 63449619 63518673 63420142 63456233 63669382 63669984 63738815 63687368 63750283 63789601 63944462 63967955 64063483 64110624 64193125 63738816 63755559 63998613 63435531 63435530 63475963 63481516 63518668 63626920 63669381 63669380 63669980 63750284 63750286 63755558 63755557 63776287 63944423 64036678 64124858 64075530 64098983 64231979 64238951 64238952 64252692 64264747 63349757 63612669 63669981 63776288 63776289 63998654 64063481 64180512 64238953 63431901 63420140 63435532 63518670 63325739 63303010 63292126 63325741 63430449 63431751 63447575 63412920 63447574 63435529 63447579 63485940 63518671 63518672 63612668 63420143 63518669 63669983 63420144 63600430 63611725 63612528 63612521 63707883 63612522 63720566 63669982 63850872 63707882 63677013 63724804 63712339 63735754 63735753 63735811 63735812 63776286 63789642 63789643 63852653 63914301 63944422 63944424 63944421 63998639 63998638 64049157 64052345 64110625 64110623 64124859 64150107 64173646 64173645 64180513 64274411 64193123 64193127 64252693 64252694 64297690 64297689 64311195 64320994 64385781 64344580 120806FP / 00690103205237 Lot Numbers: 63357594 63357593 63420147 64063364 64173648 64180591 64014035 64205467 64063363 64098991 64205466 64231980 64344676 63712342 63850874 63913720 63998641 64231805 63883326 63883325 64354898 63292129 63292127 63431914 63420146 63687372 63431920 63883322 63944428 63998607 64274415 64320996 63944466 63292128 63412923 63626929 63677015 63750287 63755566 63850947 63883328 63856364 63883323 64075772 64075783 64124861 64238969 64291999 64297691 63386793 63735817 63852678 63998656 64036546 64238967 63669385 63669987 63669988 63954333 64238970 63349758 63612682 63301465 63301468 63325725 63340209 63612525 63612687 63612530 63669384 63612683 63626925 63724806 63687371 63724805 63712341 63735760 63850869 63850928 63850942 63944426 63944465 63967949 63995684 63998606 64049162 64049165 64052350 64052347 64110630 64124918 64231798 64231799 64249780 64238968 64286010 64274416 64320997 120807FP / 00690103201789 Lot Numbers: 63358177 64014029 64085236 64098989 64274422 64173650 64052344 64098990 64442107 63677017 63687370 63967936 63998642 63883330 63883329 63292133 63412924 63883331 63998602 64049150 64063365 64205468 64231806 63755565 63735748 64124862 64231807 64274421 63850926 64036677 64075532 64220819 63364535 63431933 64193136 63301763 63386798 63431931 63449620 63611727 63612520 63634654 63626903 63677018 63724815 63712345 63856365 63944458 63954337 63995685 64085237 64286011 64297692 64320999 64274423 64437339 64344678 Fogarty Arterial Embolectomy Catheter with Stylet Models Number / UDI-DI Code: 120403FSP / 00690103205190 Lot Numbers: 63281613 63292303 63456457 64063400 63281617 63281618 63851022 63435606 63856379 63967948 63990055 63892044 64014118 64075582 63967953 63914205 64124895 64014119 63724828 64173656 64173657 64180624 64248137 64368269 63856380 64085390 63449654 63364603 64220845 120803FSP / 00690103205244 Lot Numbers: 63292306 63316450 63325827 63325828 63364604 63851032 63914366 63914211 63975628 64099016 64110683 64205557 64228638 64280765 63266285 63316451 63357903 63420194 63420195 63420196 63316452 63456475 63456496 63456472 63420193 63456497 63720572 63349821 63435611 63687388 63724837 63735634 63735633 63735635 63735763 63735755 63735813 63776327 63851029 63851030 63883801 63851028 63851027 63930591 63945551 63932061 63883809 63892049 63914210 63930592 63944463 63954399 63984734 63944469 64025799 64025800 63984735 63995712 64014120 64014117 64052420 64063404 64124910 64173664 64173663 64205559 64205558 64220849 64252746 64228636 64231986 64264819 64264816 64286059 64264815 64286061 63724838 63670051 63883803 63892048 63967947 64231816 64239090 64252747 64239091 64297825 63266286 63611738 63735637 64025801 63449655 63612161 63990056
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information ContactLinnette Torres
949-756-4582
Manufacturer Reason
for Recall		Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
FDA Determined
Cause 2		Packaging
ActionOn 10/06/2022, Edwards Lifesciences sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx 2nd Day to customer informing them that certain lots of Fogarty arterial embolectomy catheters and Fogarty biliary balloon probes are exhibiting latex deterioration in the balloon. It was determined that storage of these devices in the same room room as high energy ionizing radiation sources which can act as an ozone generator to the immediate environment, can accelerate latex deterioration and subsequent balloon failures. Advice on action to be taken by users: It is requested that they do not store Fogarty arterial embolectomy catheters and Fogarty biliary balloon probes in rooms with high energy ionizing radiation sources that could generate ozone (e.g. Fluoroscopy machines, X-ray machines, UV lights, HVAC sanitation equipment, etc). Post the attached notification as a constant reminder to their staff of the issue. - If they have devices that have been exposed to the equipment described above, please return the affected inventory with the model and lot number referenced above. - If they have devices that have not been exposed to the equipment above (e.g. stored away from high energy ionizing radiation source), they may continue to use the devices per the IFU. Review their inventory and quarantine any exposed product until prepared for return to Edwards Lifesciences. Follow the instructions included in the enclosed customer acknowledgement form and return within 5 days of receipt of this notification. Edwards Customer Service 1-800-424-3278 from 5:00 a.m. to 4:30 p.m. PST.
Quantity in Commerce715,620 units
DistributionWorldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bulgaria, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guam, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Malta, Mauritius, Morocco, Netherlands, Nicaragua, Northern Ireland, Oman, Panama, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates (UAE), United Kingdom.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DXE
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