Mahwah, NJ, United States
Maquet Datascope Corp - Cardiac Assist Division recalls
2 recalls recorded since 2018, most recently on 20 September 2018. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)2
Ongoing Class I Medical devices
- Recall started
- 20 September 2018
- Reason
- There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.
- Distribution
- US Nationwide; Internationally to 77 countries
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0099-2019, Z-0100-2019
- Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
- Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
Ongoing Class I Medical devices
- Recall started
- 3 May 2018
- Reason
- Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
- 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 th
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1928-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.