Class 2 Device Recall Impella CP Smart Assist

• Date Initiated by Firm: August 05, 2024
• Date Posted: September 04, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2968-2024
• Recall Event ID: 95129
• Product Classification: Temporary non-roller type left heart support blood pump - Product Code OZD
• Product: Impella 5.5 Set AU; Product Code: 1000361
• Code Information: Product Code: 1000361; UDI-DI: 00813502012927; Serial Numbers: 425570 425332 425331 463954 463955 476358 476357 481131 481130 481129 485279 485278 485280 480079 483437 466172A 491829 491830 491831 491832; Batch Numbers: 2024286281 2024286289 2024286292 2024375505 2024375511 2024398832 2024398833 2024413728 2024413879 2024413882 2024431078 2024431158 2024431171 2024431175 2024431650 2024431652 2024431653 2024431656 2024431673 2024431720
• Recalling Firm/ Manufacturer: Abiomed, Inc.; 24 Cherry Hill Dr; Danvers MA 01923-2575
• For Additional Information Contact: Morgaine 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: Under Investigation by firm
• Action: On 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 Commerce: 20 units
• Distribution: Worldwide 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 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.