BEUDAMED
    FDA Recall Open, Classified

    Impella RP with SmartAssist; Product Number: 0046-0035;

    Recall: Z-0829-2025 · Initiated December 12, 2024

    Recall

    Recall Number
    Z-0829-2025
    Event Number
    95780
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    PYX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 12, 2024
    Posted
    January 15, 2025
    Address
    24 Cherry Hill Dr, Danvers, MA, 01923-2575

    Description

    Impella RP with SmartAssist; Product Number: 0046-0035;

    Reason

    Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.

    Action

    On December 13, 2024, URGENT MEDICAL DEVICE CORRECTION (NOTIFICATION) letters were sent to customers. RECOMMENDATIONS: Product is not being removed and hospital inventory may continue to be used. It is recommended that users lower the pump flow level to P-2 and use imaging guidance when inserting, manipulating, or removing any guidewires, indwelling venous lines or devices to reduce the potential for interaction of the device tip with the pump inlet. If optical sensor damage occurs and Placement Signal Not Reliable (PSNR) alarm is displayed no additional actions are required. Hemodynamic support and Impella position are not affected and can be monitored as part of routine patient/pump management. In addition, calculated flow and suction monitoring are also unaffected when an optical sensor PSNR alarm is displayed. In the event of a pump stop, follow the displayed prompts of the Impella Stopped alarm. Damage to the guidewire, indwelling central venous line or other device involved in the unintended interaction should be evaluated, and users should assess if a new device is required. 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 [email protected]. - 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. 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 as per below instructions: - Complete and submit the report online: www.fda.gov/medwatch/report.htm or Regula

    Distribution

    Domestic: Nationwide Distribution International: Canada

    Quantity

    1,560 units