Home / Recalls / Maquet Datascope Corp - Cardiac Assist Division / Z-3085-2017

Z-3085-2017 Class I Ongoing

Recalled by Maquet Datascope Corp - Cardiac Assist Division — Mahwah, NJ

FDA device recall Z-3085-2017 was initiated by Maquet Datascope Corp - Cardiac Assist Division on July 17, 2017 and is designated Class I. Reason for recall: 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. The recall status is ongoing. Affected quantity: 14,547 units (5,049 domestically & 9,498 units internationally).

Recall Details

Product Type: Devices
Report Date: September 13, 2017
Initiation Date: July 17, 2017
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14,547 units (5,049 domestically & 9,498 units internationally)

Product Description

CS 100i 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 end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.

Reason for Recall

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.

Distribution Pattern

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 REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALDIVES, MALTA, MAURITIUS, MEXICO, MOROCCO, MYANMAR, NEPAL, NETHERLANDS, NEW ZEALAND, NORTH KOREA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TUNISIA, TURKEY, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM & YEMEN.

Code Information

0998-UC-0446HXX; 0998-UC-0479HXX

Other recalls by Maquet Datascope Corp - Cardiac Assist Division

Z-0100-2019 Class I — Cardiosave Rescue IABP, Part Number 0998-UC-0800-83 (September 20, 2018)
Z-0099-2019 Class I — Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 (September 20, 2018)
Z-1928-2018 Class I — CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX (May 3, 2018)
Z-3086-2017 Class I — CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by i (July 17, 2017)
Z-3087-2017 Class I — CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by i (July 17, 2017)
Z-2738-2017 Class I — CS 300 Intra-Aortic Balloon Pump (June 16, 2017)
Z-2737-2017 Class I — CS 100 Intra-Aortic Balloon Pump (June 16, 2017)
Z-2736-2017 Class I — CS 100i Intra-Aortic Balloon Pump (June 16, 2017)
Z-1386-2017 Class II — CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998- (December 23, 2016)
Z-1248-2016 Class II — Cardiosave Hybrid and rescue IABP (December 16, 2015)