Z-3085-2017Class I

CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion...

Name: Z-3085-2017 CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion...
Creator: Maquet Datascope Corp - Cardiac Assist Division
Published: 2017-07-17
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2017-07-17 / Open, Classified

FDA source

Maquet Datascope Corp - Cardiac Assist Division began a recall of CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary... on 2017-07-17. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3085-2017
Classification: Class I
Status: Open, Classified
Initiated: 2017-07-17
Posted: 2017-09-05
Recalling firm: Datascope Corp.
Product: 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.
Product code: DSP System, Balloon, Intra-Aortic And Control
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.
FDA 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 clinicians are instructed not to leave the patient unattended during IABP therapy pursuant to Warnings listed in the Operating Manual. o For Blood Detection Alarm - Until the service is performed, clinicians are instructed to follow the Blood Detection Alarm Help Screen found in the operating instruction to validate or clear the alarms. Maquet/Getinge recommends that users review the water condensation procedure (CS100/CS100i and CS300 IABP Operating Instructions section 3.4.1) to reduce the potential for condensation accumulation. In the event the IABP fails to successfully cycle and clear the alarm, remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office. o For Fluid Ingression - Until the service is performed, Maquet/Getinge recommends customers review of the CS100/CS100i and CS300 IABP Operating instructions regarding cautions on placement of fluids and hanging of bags of fluid over the IABP. All facilities will be contacted by a representative of the Maquet/Getinge Service Team to schedule on-site service of your CS100/CS100i or CS300 IABP. Customers are advised to complete and return the Medical Device Field Correction Response Form. Please fax the completed form to 1-973-629-1690 or send via email to [email protected]. If you a distributor has shipped any affected products to customers, please forward a copy of the docu
Quantity in commerce: 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 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.
Product codes and lots: 0998-UC-0446HXX; 0998-UC-0479HXX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3085-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3085-2017	Class I	Ongoing	Voluntary: Firm initiated	2017-09-13	2017-09-05
Z-3086-2017	Class I	Ongoing	Voluntary: Firm initiated	2017-09-13	2017-09-05
Z-3087-2017	Class I	Ongoing	Voluntary: Firm initiated	2017-09-13	2017-09-05

Product code DSP

K031636Class IICs100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XxDatascope Corp. / cleared 2003-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)