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-2958-2024
Recall Event ID 95129
Product Classification Temporary non-roller type left heart support blood pump - Product Code OZD
ProductImpella CP Smart Assist Set, Canada; Product Code: 0048-0044;
Code Information Product Code: 0048-0044; UDI-DI: 00813502012200; Serial Numbers: 383487 383488 383489 381637 381777 381640 381639 381638 379660 379659 379661 372534 372535 386882 389812 389809 389811 389814 389813 386881 386879 386880 386943 388495 388498 391472 391470 391471 387330 387329 387333 387332 387331 389489 389493 389491 389490 389492 387328 388467 388465 388527 388528 388469 388470 388471 386005 386001 386008 386006 386007 386004 386170 386168 386169 386003 385999 386009 385933 385931 385921 386000 385938 385939 385940 385923 385922 386010 385935 385937 385934 390915 390914 390913 390912 392642 392643 392644 392534 392535 392537 392538 392640 392641 392536 392835 392834 392829 392828 392903 392902 392836 392837 392833 392906 392824 392831 392830 392826 392825 393083 393082 393079 393080 393081 427384 427383 427382 427381 427379 428638 428639 428640 428630 428641 428642 428631 428629 428623 428632 429793 429780 429794 429784 429786 429787 429788 430901 429789 428645 428646 429770 431699 431702 431700 431701 431695 430897 430898 430899 433880 429771 433881 431694 431696 431698 430900 430904 430903 430902 429792 429785 429782 429797 429791 429790 435973 435975 435974 435976 435149 435152 435150 435151 435148 438046 438047 438045 438040 438041 438042 438043 438044 438048 438694 445510 445509 445514 445513 445517 445511 436001 445516 436000 435999 451167 445521 445550 445557 451173 453374 453376 453368 453236 450524 451168 450521 450541 445520 445527 450520 445524 445518 445519 445526 445525 455398 455397 455394 450518 450519 450523 454032 445549 445554 453427 453425 453231 453155 453230 453158 453426 453428 453154 453153 453369 453237 453235 453375 453373 453228 453157 453156 453370 453371 453372 453229 453234 453377 453232 445555 453233 445551 445552 451165 431647 431648 453971 453572 453571 451172 451656 452098 450544 451166 451171 452082 452083 451724 451662 451657 451725 453972 453570 455396 453424 454033 454035 453967 452099 452103 451723 453966 452076 453968 452081 454029 454037 454030 454031 454034 453974 453567 453573 445553 453569 452077 486295 486271 486272 486273 478008A 486259 486296 486270 486274 486276 486277 486278 486279 474327 474328 486275 474329 474330 474331 487612 487613 487614 487615 487616 493536 493537 493538 493539 493540 493541 493542 493544 493545 489740 489743 493546; Batch Numbers: 2023212081 2023212080 2023212079 2023206026 2023206024 2023206029 2023206028 2023206027 2023204432 2023204428 2023204436 2023204441 2023204447 2023222485 2023227971 2023227974 2023227973 2023227964 2023227968 2023222483 2023222479 2023222481 2023222478 2023233647 2023233646 2023233656 2023233652 2023233654 2023248877 2023248873 2023248885 2023248882 2023248880 2023236762 2023236770 2023236766 2023236764 2023236769 2023252334 2023252332 2023252331 2023256979 2023256976 2023256973 2023256974 2023256975 2023266986 2023266989 2023266975 2023266979 2023266981 2023266983 2023266996 2023266993 2023266995 2023266991 2023268388 2023268395 2023268409 2023268407 2023268406 2023268391 2023268420 2023268422 2023268423 2023268401 2023268404 2023268398 2023268413 2023268418 2023268412 2023282144 2023282137 2023282127 2023282121 2024285344 2024285345 2024285347 2024285349 2024285351 2024285354 2024285357 2024285340 2024285342 2024285353 2024295406 2024295404 2024295422 2024295417 2024295385 2024295388 2024295415 2024295394 2024295402 2024295391 2024295432 2024295427 2024295425 2024295435 2024295434 2024306035 2024306040 2024306052 2024306049 2024306043 2024311479 2024311482 2024311484 2024311486 2024311489 2024315119 2024315124 2024315129 2024315159 2024315131 2024315143 2024315163 2024315158 2024315171 2024315167 2024319237 2024319251 2024319249 2024319266 2024319268 2024319271 2024319274 2024328109 2024319275 2024319277 2024319280 2024331031 2024331045 2024331051 2024331047 2024331049 2024331038 2024338407 2024338424 2024338432 2024338436 2024331020 2024338439 2024331035 2024331041 2024331044 2024328106 2024328120 2024328117 2024328113 2024342709 2024342716 2024342715 2024342708 2024342714 2024342712 2024342717 2024342719 2024342718 2024342720 2024355494 2024355482 2024355492 2024355490 2024355497 2024365370 2024365372 2024365360 2024365346 2024365349 2024365352 2024365354 2024365356 2024365376 2024365379 2024371719 2024371722 2024371711 2024371713 2024371707 2024371716 2024371699 2024371703 2024371697 2024371696 2024377459 2024377420 2024377421 2024377423 2024377466 2024378541 2024378543 2024378548 2024378550 2024374379 2024377463 2024374376 2024375071 2024374343 2024374351 2024374374 2024374345 2024374362 2024374341 2024374349 2024374347 2024380603 2024380606 2024380617 2024374370 2024374372 2024374378 2024380639 2024375087 2024375093 2024378526 2024378528 2024378555 2024378532 2024378556 2024378529 2024378527 2024378524 2024378533 2024378534 2024378547 2024378549 2024378551 2024378542 2024378540 2024378558 2024378530 2024378531 2024378535 2024378538 2024378539 2024378557 2024378552 2024378546 2024378554 2024375095 2024378553 2024375088 2024375089 2024377457 2024377431 2024377430 2024380682 2024380704 2024380702 2024377465 2024374323 2024375101 2024375083 2024377458 2024377464 2024377452 2024377454 2024375147 2024374335 2024374325 2024375149 2024380685 2024380700 2024380609 2024380631 2024380645 2024380648 2024380665 2024375104 2024375133 2024375145 2024380658 2024377433 2024380668 2024377450 2024380633 2024380651 2024380636 2024380638 2024380646 2024380688 2024380691 2024380706 2024375090 2024380693 2024377440 2025495546 2025495553 2025495556 2025495559 2025495538 2025495540 2025495544 2025495549 2025495564 2025495572 2025495575 2025495578 2025495580 2025495585 2025495619 2025495570 2025495620 2025495621 2025495622 2025505201 2025505205 2025505208 2025505210 2025505212 2025517258 2025517259 2025517261 2025517263 2025517265 2025517266 2025517267 2025517268 2025517269 2025517271 2025517283 2025517284;
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 Commerce323 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.
-
-