CS 100i Intra-Aortic Balloon Pump recallZ-2736-2017 · Maquet Datascope Corp - Cardiac Assist Division · initiated Jun 16, 2017
Class I Terminated All recalls posted in June 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Datascope Corp - Cardiac Assist Division or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component design/selection
What the company is doing
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
Recall details
- Recall number
- Z-2736-2017
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Jun 16, 2017
- Posted by the FDA
- Jun 23, 2017
- Recalling firm
- Maquet Datascope Corp - Cardiac Assist Division
- Quantity
- 12,319 units total
- Product code
- DSP
- FDA submissions
- K031636
- Distribution
- Worldwide Distribution - (in over 100 countries) US (Nationwide)
Product description
CS 100i Intra-Aortic Balloon Pump
Code information (models, lots, serial numbers)
0998-UC-0446HXX 0998-UC-0479HXX
Other devices under the same FDA submission
21 devices cleared under K031636 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CS100 Intra-Aortic Balloon Pump, English, 220V 0998-00-3013-55Datascope Corp. · System, Balloon, Intra-Aortic And Control4 deaths933 reports
- CS100 Intra-Aortic Balloon Pump, Chinese, 220V 0998-00-3013-45Datascope Corp. · System, Balloon, Intra-Aortic And Control2 deaths684 reports
- CS100 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,NON-UTS,INTL 0998-UC-3013-55Datascope Corp. · System, Balloon, Intra-Aortic And Control1 death129 reports
- CS100 Intra-Aortic Balloon Pump, Japanese, 110V 0998-00-3013-65Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall1 death60 reports
- CS100 Intra-Aortic Balloon Pump, Spanish, 220V 0998-00-3013-58Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall32 reports
- CS100 Intra-Aortic Balloon Pump, Portuguese, 110V 0998-00-3013-69Datascope Corp. · System, Balloon, Intra-Aortic And Control66 reports
- CS100 Intra-Aortic Balloon Pump, Italian, 220V 0998-00-3013-67Datascope Corp. · System, Balloon, Intra-Aortic And Control65 reports
- CS100 Accessory Kit, Spanish, 220 V 0020-00-0463-05Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall0 reports
- CS100 Intra-Aortic Balloon Pump, Portuguese, 220V 0998-00-3013-68Datascope Corp. · System, Balloon, Intra-Aortic And Control49 reports
- CS100 Intra-Aortic Balloon Pump, French, 220V 0998-00-3013-64Datascope Corp. · System, Balloon, Intra-Aortic And Control16 reports
- CS100 Intra-Aortic Balloon Pump, Refurbished, CHINESE,NON-UTS,INTL 0998-UC-3013-45Datascope Corp. · System, Balloon, Intra-Aortic And Control13 reports
- CS100 Intra-Aortic Balloon Pump, Refurbished, JAPANESE,NON-UTS,DOM 0998-UC-3013-65Datascope Corp. · System, Balloon, Intra-Aortic And Control11 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 77566).
- Z-2737-2017 · TerminatedCS 100 Intra-Aortic Balloon Pump
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page