Z-2736-2017Class I

CS 100i Intra-Aortic Balloon Pump

Name: Z-2736-2017 CS 100i Intra-Aortic Balloon Pump
Creator: Maquet Datascope Corp - Cardiac Assist Division
Published: 2017-06-16
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2017-06-16 / Terminated / root cause: design

FDA source

Maquet Datascope Corp - Cardiac Assist Division began a recall of CS 100i Intra-Aortic Balloon Pump on 2017-06-16. FDA classified it as Class I and gives the reason as "The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2736-2017
Classification: Class I
Status: Terminated
Initiated: 2017-06-16
Posted: 2017-06-23
Terminated: 2019-11-29
Recalling firm: Datascope Corp.
Product: CS 100i Intra-Aortic Balloon Pump
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
Root cause tag: design
FDA root cause: Component design/selection
Action: Datascope Corp/MAQUET issued a press release on June 16, 2017. Datascope Corp/MAQUET sent an Urgent Product Recall Letter on June 19, 2017, to their customers via FedEx next day delivery service. Pursuant to the WARNINGS section of our CS100i, CS100 or CS300 IABP Operating/User Instructions, clinicians are instructed not to leave the patient unattended during IABP therapy. Until the service is performed, we recommend the IABP be powered on prior to initiation of therapy to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to perform. In the event the IABP fails to successfully complete the self-test and exhibits electrical test failure code 58, please remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office. Customers will be instructed to complete and return the attached Medical Device Field Correction Response Form via fax to 1-973-807-9217 or send via email to [email protected]@getinge.com. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. For U.S. customers with technical questions, please contact our Technical Support Department (at 1-888-627-8383 and press 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST
Quantity in commerce: 12,319 units total
Distribution: Worldwide Distribution - (in over 100 countries) US (Nationwide)
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-2736-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2736-2017	Class I	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-27
Z-2737-2017	Class I	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-27
Z-2738-2017	Class I	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-27

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)