Recall Z-1928-2018 ยท DSP System, Balloon, Intra-Aortic And Control
Maquet Datascope Corp - Cardiac Assist Division
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
| Date | May 3, 2018 |
| Status | Open, Classified |
| Reason | Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy. |
| Root 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |