Class 2 Device Recall Abiomed

• Date Initiated by Firm: November 07, 2023
• Date Posted: January 05, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0653-2024
• Recall Event ID: 93501
• Product Classification: Introducer, catheter - Product Code DYB
• Product: Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
• Code Information: UDI-DI: N/A
• Recalling Firm/ Manufacturer: Abiomed, Inc.; 24 Cherry Hill Dr; Danvers MA 01923-2575
• For Additional Information Contact: SAME; 978-646-1400
• Manufacturer Reason for Recall: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
• FDA Determined Cause: Process control
• Action: Abiomed issued URGENT MEDICAL DEVICE RECALL (REMOVAL) Letter Products Impacted: Introducer Kit for Impella (sold within Impella Pump sets and Individually Packaged) Axillary Introducer Kits on 11/7/23. Letter states reason for recall, health risk and action to take: IF AN IMPELLA PUMP IS CLINICALLY NEEDED, ACTIONS TO BE TAKEN BY THE USER: 1. Prior to usage, carefully examine the outer pouch of the Introducer Kit for holes following the provided instructions in Attachment 2. 2. For non-trayed introducers (Part Numbers 0052-3006): IF THERE IS ANY SUSPICION OF THIS TYPE OF PACKAGING DAMAGE, REFRAIN FROM USING THE PRODUCT. 3. For trayed introducers with an inner tray package (Part Numbers 0052-3014, 0052-3015, 0052-3021, 0052-3052, 0052-3046, 0052-3025, 0052-3056, 2000342, 0052-3053): Consider that while the outside surface of the tray is non-sterile, the introducers inside the tray are considered sterile. After removing the inner tray from the outer pouch, avoid introducing it to the sterile field. Instead, employ sterile technique to open the inner tray, preserving its interior sterility. a. Transfer the contents from the inner tray to the sterile field following your institution s sterile field management protocol, ensuring no contact with the outer surface to prevent contamination. b. The inner tray must remain separate from the sterile field and should be discarded once all components of the introducer kit have been extracted. 4. If used, document the use on the Business Request Form at the end of this letter. Please contact Abiomed s Clinical Support Center, 1-800-422-8666, if you need any support troubleshooting or if you have any further questions.
• Quantity in Commerce: 1 unit within kit
• Distribution: Nationwide Foreign: Country AT AU BE BR CA CA CH CZ DE DK ES FR FR HK IN IT MX MY NL NO PA SG TW UK
• 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.