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U.S. Department of Health and Human Services

Class 1 Device Recall Impella 5.5 with SmartAssist

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  Class 1 Device Recall Impella 5.5 with SmartAssist see related information
Date Initiated by Firm April 17, 2023
Date Posted May 18, 2023
Recall Status1 Open3, Classified
Recall Number Z-1590-2023
Recall Event ID 91955
PMA Number P140003 
Product Classification Temporary non-roller type left heart support blood pump - Product Code OZD
Product Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
Code Information Impella 5.5 JP(1000211) Serial Numbers: 368476 375832 379587 379685 381256 381255 381642 385162 385180 385179 385641 385666 385671 385674 386036 386037 386045 386058 386128 386133 386134 386132 386138 386143 386149 386147 387492 387498 385548 385546 385549 387509 387506 404248 404251 387526 404272 387502 387501 387503 387518 387515 387532 387825 405172 405171 405170 405175 405173 405176 405177 406161 406342 404263 406171 406170 405464 405472 405471 405704 404267 404266 404285 404283 404307 404696 404698 404699 404745 405246 405860 405859 405862 405968A 406175 406173 404292 406176 Impella 5.5 Smart Assist (0550-0002) Serial Numbers: 321271 333003 333035 333043 334696 345239 360280 360511 365273 365274 367019 367021 370130 370129 375223 375221 375671 381808 381809 384612 384834 397290 394926 395381 398208 398567 403771 403886 403884 404028 397198 397200 397284 397281 397295 397294 397291 397309 397307 397310 397306 397499 397496 397500 397498 403114 407858 407868 407873 407872 407234 408363 408365 408572 411385 411444 412012 412360 412359 413091 413092 413643 413930 413931 416785 406330 406329 406331 405433 405435 405434 404452 405714 405715 404938 404940 406378 406381 405946 405947 405469 405603 405607 405710 405709 404746 404812 404808 404915 404916 404964 405147 Impella 5.5 with SmartAssist Set, US (0550-0008) Serial Numbers: 313711 313730 313762 313780 316678 317849 319440 320326 320332 320593 321229 321274 323883 323887 323958 324062 324151 324292 324328 324340 324342 325116 326264 326320 326529 329919 331667 331668 332082 332086 333730 333743 333761 334699 334702 336068 336775 336788 338606 338638 339419 339647 339723 340789 341182 341992 342461 342463 342685 342901 342903 343302 344979 345850 347527 348215 348613 349427 349642 349644 349646 349648 349668 350162 351174 351312 352938 352939 353150 354051 355116 355118 356497 356505 356516 356520 357004 357019 357021 357154 357156 357282 357801 357802 358264 358582 358823 360276 361205 361618 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Recalling Firm/
Manufacturer		 Abiomed, Inc.
22 Cherry Hill Dr
Danvers MA 01923-2575
For Additional Information Contact Shashi Thoutam
734-262-6255
Manufacturer Reason
for Recall		 The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
FDA Determined
Cause 2		 Device Design
Action An URGENT MEDICAL DEVICE RECALL (REMOVAL) notification letter dated 4/17/23 was sent to customers. ACTIONS RELATED TO THIS RECALL (REMOVAL) Abiomed will replace all affected pumps that are still in your inventory using a phased replacement approach. The benefits of using the pump outweigh the risks of pump stop due to purge leaks. To mitigate leaks from sidearm damage and/or the yellow luer, it is critical to refer to the Important Information section below for best practices in the event you must use an affected Impella 5.5 with SmartAssist Set while you wait for a replacement pump. Please contact your Abiomed representative to receive a Sidearm Retainer and/or a Codan Extension Tubing Set if you do not have one. See Attachment 1 to this letter for your specific replacement date. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal). Refer to Attachment 1 for the Product Identification Tool to identify products that are subject to this Recall (Removal) by using package labels. DO NOT USE THE SUBJECT PRODUCTS UNLESS NO OTHER PRODUCT IS AVAILABLE. 2. Contact the Abiomed customer support center to coordinate the return of the subject products according to your scheduled date in Attachment 1. 3. Review the IMPORTANT INFORMATION section above for best practices in the event you must use these devices while you wait for a replacement. 4. Review, complete all fields, sign, and return the attached Business Response Form (BRF) on the last page of this letter to the Recall Coordinator identified in this document. IMPORTANT: Please complete the attached Business Response Form even if you have used any units of the subject product on hand. 5. Forward this notice to any personnel in your facility who need to be informed. 6. If any of the product subject to this recall (removal) has been forwarded to another facility, contact that facility and provide a copy of this notice to the releva
Quantity in Commerce 610 units
Distribution US Nationwide. Japan, Saudi Arabia, Kuwait, Italy, Spain, Switzerland, Austria, France, Great Britain, Croatia, Serbia, Norway, Slovenia, Germany
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = OZD and Original Applicant = ABIOMED, INC.
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