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U.S. Department of Health and Human Services

Class 2 Device Recall Impella CP Smart Assist

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 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-2961-2024
Recall Event ID 95129
Product Classification Temporary non-roller type left heart support blood pump - Product Code OZD
ProductImpella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
Code Information Product Code: 0550-0002; UDI-DI: 00813502011630; Serial Numbers: 384019 384018 384017 384016 383757 383754 383756 383755 384616 384617 384613 384609 384594 384614 384615 384610 384611 384612 384709 384623 384622 384620 384619 384793 384792 384713 384712 384711 384790 384789 384888 384887 384886 384885 384791 384884 384813 384812 384810 384809 384838 384837 384836 384835 384871 384872 384834 384870 384869 397290 397289 393811 393812 393810 393809 397288 393808 397287 397286 395384 395383 394929 395382 395381 394926 394925 394928 394927 395380 398211 398210 398208 398566 398567 398207 400356 400355 400359 400358 400357 398569 400394 400392 400391 400390 403768 403662 403661 403659 403658 403483 403481 403482 403480 403771 403770 403264 397285 397282 397281 397284 397200 397199 397198 397197 397196 397130 397294 397295 397292 397293 397291 397499 397498 397496 397309 397310 397308 397307 397306 397500 397296 398570 397305 397304 397301 397303 397302 403265 403266 403769 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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 Commerce1,889 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.
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