The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Datascope Corp./MAQUET Intra-Aortic Balloon Pump
- Model/Item Numbers: CS100i, CSO100, CS300
- Lot Numbers: All Lots Manufactured July 1, 2003 to June 16, 2017
- Manufacturing Dates: July 1, 2003 to June 16, 2017
- Distribution Dates: March 24, 2003 to June 16, 2017
- Devices Recalled in the U.S.: 5,049
Datascope Corp./MAQUET's CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps (IABP) are cardiac assist devices used to assist patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure.
Image of a Datascope Corp./MAQUET Intra-Aortic Balloon Pump
Reason for Recall
Datascope Corp./MAQUET is recalling its CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps manufactured July 1, 2003 to June 16, 2017 due to False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump. If a patient requires circulatory support with an IABP and the device does not work, or if therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.
Who May be Affected
- Hospitals and health care professionals using a Datascope Corp./MAQUET Intra-Aortic Balloon Pump that was manufactured July 1, 2003 to June 16, 2017 and has not been serviced and upgraded by the manufacturer.
- Patients receiving circulatory support with a Datascope Corp./MAQUET Intra-Aortic Balloon Pump that was manufactured July 1, 2003 to June 16, 2017.
What to Do
On July 17, 2017, Datascope Corp./MAQUET sent affected customers an "Urgent Product Recall Medical Device Field Correction" notice informing them of the device's risks, and listing actions that should be taken to minimize the risk of patient harm until affected IABP units can be serviced. The firm recommends that the risks and benefits of using an affected CS100i, CS100, or CS300 IABP be assessed by the medical team for each patient when no alternative IABP or alternative therapy is available.
The notice asked customers to please adhere to the following instructions:
- Check inventory to identify any affected IABP units that may be stored or are currently in use.
- Pursuant to the User Instruction Warnings, health care providers are instructed not to leave a patient unattended during IABP therapy.
- Be aware that customers with affected IABP unit(s) will be contacted by a representative of the Maquet/Getinge Service Team to schedule on-site service to install gaskets in the IABP unit(s) and upgrade software.
- Until the affected unit is serviced for the potential false blood detection alarm, clinicians should follow the instructions on the Blood Detection Alarm Help Screen to validate or clear the alarms.
- Maquet/Getinge recommends that users review the water condensation procedure to reduce the potential for condensation accumulation.
- In the event the IABP fails to successfully cycle and clear the alarm, please remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office.
- Until the affected unit is serviced for the potential fluid ingression into the IABP, users should review the operating instructions regarding cautions on placement of fluids and hanging of bags of fluid over the IABP.
- Customers are instructed to complete and return the Medical Device Field Correction Response Form enclosed in the notice via fax to 1-973-807-9217, or email at: IABP2017TWO@getinge.com.
- If you are a distributor who has shipped any affected products to customers, please forward the Urgent Product Recall Medical Device Field Correction Notice to their attention for appropriate action.
Customers with questions regarding this field correction may contact Datascope Corp./MAQUET's Technical Support Department at 1-(888)-627-8383 and press "2" (Monday through Friday from 8:00 a.m. to 6:00 p.m. EDT).
Date Recall Initiated
July 17, 2017
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Health care professionals employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.