Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Impella CP Smart Assist

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Impella CP Smart Assistsee related information
Date Initiated by FirmAugust 05, 2024
Date PostedSeptember 04, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2970-2024
Recall Event ID 95129
Product Classification Temporary non-roller type left heart support blood pump - Product Code OZD
ProductImpella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
Code Information Product Code: 1000459; UDI-DI: 00813502013054; Serial Numbers: 491248 491249 491975 491974 490744 491976 491977 490747 490725 490739 490740 490741 490742 490743 490727 491252 491239 491253 491235 491241 492012 490724 492009 491246 492005 492010 492011 491981 491240 491243 493477 491982 493476 493478 493480 493479 492004 490745 494684 494686 494687 493837 493838 493839 494689 494688 494690 494691 494692 494693 490746 494734 491236 494736 493836 494735 499143 494737 494738 491242 493840 492013 499157 499148 499156 491237 491978 494743 499153 499144 501038 501071 499155 499150 501132 499154 490728 499152 499168 501040 499738 499744 499170 501183 499740 499739 499741 501186 501041 499743 499746 501093 501205 492008 499742 501097 501094 501128 501129 501130 501184 501131 501054 491245 501204 504904 501039 501057 499147 501069 501070 501207 501213 501215 501187 498548 491238 498549 498930 501217 501072 501206 504888 491979 507422 504890 494740 504891 504893 501042 499745 499747 501056 501185 505122 507318 505123 504909 498552 498929 504913 504907 490748 494739 504879 507414 506589 504882 504883 505889 492007 504885 505890 494742 498928 501203 504905 498945 498943 498949 499145 501214 507371 507372 507315 507317 498946 506590 498550 506591 506592 498964 504884 498965 498966 498931 498973 498967 504908 498974 498975 498944 498977 506607 498950 498952 498963 498551 498553 507383 498555 498556 506606 507369 498557 504889 505121 504880 498932 498968 498554 504911 498972 506593 498969 507380 507379 498976 507418 507420 509243 501216 509247 509244 498970 505120 509246 509231 509232 509289 509245 504910 504906 509230 507373 507316 507381 509199 498971 509202 505891 509228 509288 511242 511241 509291 512372 504912 507314 511259 511260 511261 511262 512373 507416 507417 511239 511275 509163 509166 509164 512924 505892 501053 504886 512927 512928 512939 507419 498947 498948 507370 512942 512943 511240 509167 511279 511280 505119 511263 512371 511282 507382 509198 512940 512966 511243 511283 511274 512967 512968 507423 511276 513195 513196 513198; Batch Numbers: 2024434436 2024434438 2025437468 2025437135 2025441891 2025437471 2025437477 2025441898 2024434429 2025437487 2025437489 2025437490 2025437491 2025437496 2024434430 2025437499 2025437511 2025437503 2024434412 2025437523 2025437567 2024434426 2025437535 2024434435 2025441844 2025437547 2025437564 2025437612 2025437521 2025437531 2025441826 2025437613 2025441819 2025441831 2025441838 2025441834 2025441841 2025441893 2025444069 2025444070 2025444072 2025444134 2025444137 2025444224 2025444074 2025444073 2025444075 2025444091 2025444103 2025444108 2025441895 2025444113 2024434420 2025444122 2025444133 2025444120 2025455128 2025444126 2025444128 2025437525 2025444226 2025437594 2025455115 2025455119 2025455101 2024434421 2025437483 2025444241 2025454400 2025455130 2025459792 2025459845 2025455100 2025455121 2025459821 2025455097 2024434431 2025455124 2025455136 2025459797 2025459770 2025459823 2025455140 2025458975 2025459781 2025459775 2025459786 2025459944 2025459800 2025459822 2025459827 2025459806 2025459932 2025441890 2025459789 2025459812 2025459809 2025459814 2025459815 2025459817 2025459766 2025459818 2025459832 2024434433 2025459931 2025469865 2025459794 2025459837 2025455134 2025459838 2025459840 2025459936 2025459937 2025459939 2025459946 2025449406 2024434424 2025449532 2025449543 2025459942 2025459862 2025459935 2025466151 2025437599 2025471896 2025466038 2025444234 2025466039 2025466042 2025459803 2025459826 2025459829 2025459836 2025459943 2025466055 2025471889 2025466064 2025466069 2025449537 2025449540 2025466089 2025469879 2025441900 2025444232 2025469941 2025471890 2025469881 2025470020 2025470021 2025470022 2025441888 2025466140 2025470046 2025444239 2025449538 2025459926 2025469867 2025451117 2025451113 2025451126 2025455132 2025459938 2025471861 2025471864 2025471875 2025471887 2025451118 2025469934 2025449534 2025469936 2025469937 2025452562 2025466093 2025452565 2025452567 2025449546 2025452569 2025452568 2025470297 2025452570 2025452574 2025451114 2025452579 2025470067 2025451159 2025451163 2025452551 2025449536 2025452582 2025471840 2025452585 2025452587 2025470069 2025471856 2025452588 2025466014 2025466050 2025469996 2025449551 2025452592 2025452584 2025466083 2025452605 2025469940 2025452595 2025471836 2025471835 2025452577 2025471893 2025471895 2025477614 2025459940 2025477628 2025477620 2025452598 2025466047 2025477623 2025477644 2025477651 2025477661 2025477622 2025466078 2025469870 2025477641 2025471867 2025471885 2025471837 2025477674 2025452602 2025477676 2025470047 2025477638 2025477655 2025481034 2025481022 2025477663 2025481070 2025466086 2025471868 2025481083 2025481088 2025481096 2025481106 2025481076 2025471891 2025471892 2025481009 2025481118 2025481162 2025481186 2025481173 2025486381 2025470066 2025459830 2025466145 2025486416 2025486420 2025486423 2025471894 2025451122 2025451124 2025471859 2025486437 2025486441 2025481019 2025481198 2025489120 2025489128 2025466044 2025481113 2025481053 2025489135 2025471839 2025477671 2025486428 2025489165 2025481038 2025489139 2025481116 2025489177 2025489185 2025471897 2025481123 2025489200 2025489208 2025489306;
Recalling Firm/
Manufacturer		 Abiomed, Inc.
24 Cherry Hill Dr
Danvers MA 01923-2575
For Additional Information ContactMorgaine Johnson
612-437-5734
Manufacturer Reason
for Recall		A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn August 5, 2024 URGENT MEDICAL DEVICE CORRECTION (NOTIFICATION) letters were sent to consignees. ACTIONS TO BE TAKEN BY CUSTOMER/USER: " Product is NOT being removed from the field and does not need to be returned. " Review, complete all fields, sign, and return the attached business response form (BRF) (refer to Attachment 2) to Abiomed2860@SEDGWICK.COM. " Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products). " If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. " Post a copy of this notice in a visible area for awareness of this field safety notice. " As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA s MedWatch Adverse Event Reporting Program using the link below: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda At Abiomed, our priority is to our customers and their patients, and that includes the safe and effective use of our products. If you have questions or concerns regarding this notice, please contact your local clinical field staff. Thank you for your cooperation.
Quantity in Commerce286 units
DistributionWorldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., 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.
-
-