Recall Z-3087-2017 ยท DSP System, Balloon, Intra-Aortic And Control
Maquet Datascope Corp - Cardiac Assist Division
CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic en
| Date | Jul 17, 2017 |
| Status | Open, Classified |
| Reason | False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy. |
| Root cause | Under Investigation by firm |
| Action | On July 17, 2017, Maquet/Getinge distributed Urgent Product Recall Medical Device Field Correction and Response Form notices to their U.S. customers via FedEx. Urgent Field Safety Medical Device Field Correction notices were distributed to international customers via email and courier service. Maquet/Getinge advised affected customers to perform risk-benefit assessments with their respective medical team for each patient, when no alternative IABP or alternative therapy is available. Maquet/Getinge provided general information and overall action for the user informing them that: o The clini |
| Quantity | 14,547 units (5,049 domestically & 9,498 units internationally) |
| Distribution | Worldwide Distribution - US Nationwide International: AFGHANISTAN, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUB |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump Datascope Corp., Jul 2, 2015 |