Class 1 Device Recall CARDIOSAVE Hybrid Intraaortic Balloon Pump (IABP)

• Date Initiated by Firm: May 03, 2018
• Create Date: May 31, 2018
• Recall Status: Open, Classified
• Recall Number: Z-1928-2018
• Recall Event ID: 80003
• 510(K)Number: K112372 K151254
• Product Classification: System, balloon, intra-aortic and control - Product Code DSP
• Product: CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179
• Code Information: All Serial Numbers distributed from 03/06/2012 to 04/26/2018
• Recalling Firm/ Manufacturer: Maquet Datascope Corp - Cardiac Assist Division; 1300 Macarthur Blvd; Mahwah NJ 07430-2052
• For Additional Information Contact: 973-244-6138
• Manufacturer Reason for Recall: Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
• FDA Determined Cause: Device Design
• Action: Notification of the field correction was posted to the firm's website on 5/3/18 at https://www.maquet.com/globalassets/downloads/product-articles/cardiosave/ml_0730_us_rev_a_cardiosave_fluid_ingress_recall_customer_letter_us_4may2018.pdf. Mailed notification letters will be issued to customers as well. The instructions included in the notification includes the following: Patients receiving IABP therapy are in critical condition. Failure to start or sudden interruption of therapy could result in unsafe, hemodynamic instability. Until the protective top cover is installed, please adhere to the following instructions when using Cardiosave intra-aortic balloon pump: 1) Pursuant to the Caution section of our Cardiosave IABP Operating/User Instructions, Never place fluids on top of this unit. Make sure that the saline container and tubing do not hang directly over the IABP. In case of accidental spillage, wipe clean immediately and have the unit serviced to ensure no hazard exists In the unlikely event that a sudden interruption of therapy occurs, transfer the patient to an alternative IABP. The Intra-Aortic Balloon (IAB) Catheter Instructions for Use reiterates that a catheter should not remain inactive for more than 30 minutes, due to the potential for thrombus formation. If an alternative IABP is unavailable; manually inflate the IAB with air or helium and immediately aspirate, repeat every 5 minutes until either an alternate IABP is available or alternatively, the intra-aortic balloon catheter should be removed from the patient. Please refer to the intra-aortic balloon catheter instructions for use, Manually Inflating and Deflating a Catheter. The patient should be treated according to your facilitys treatment protocols and caregivers clinical judgment to ensure hemodynamic stability. Affected customers will be contacted by a Maquet/Getinge representative to schedule on-site service of your Cardiosave IABP by a Maquet/ Getinge Sales or Service Re
• Quantity in Commerce: 4300
• Distribution: The devices were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Guam. The devices were distributed to the following foreign countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Brunei, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrica, Taiwan, Thailand, Turkey, UAE, UK, Vietnam, Yemen.
• 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.

• 510(K) Database: 510(K)s with Product Code = DSP; 510(K)s with Product Code = DSP