CS100 Intra-Aortic Balloon Pump recallZ-1811-2010 · Datascope Corporation · initiated May 10, 2010
Terminated All recalls posted in June 2010
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 Datascope Corporation 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
Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related issues. Although the IABP continues to deliver therapy to the patient, display related issues may cause the user to be unable to view the IABP on the information screen.
FDA root cause category: Other
What the company is doing
Medical Device Recall Letters were sent to Hospital Administrators beginning May 10, 2010 by overnight mail. Customers with questions are directed to contact your local Sales/Service Representative or the company representative at 973-244-6314.
Recall details
- Recall number
- Z-1811-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 10, 2010
- Posted by the FDA
- Jun 21, 2010
- Recalling firm
- Datascope Corporation
- Quantity
- 161 total devices
- Product code
- DSP
- FDA submissions
- K031636
- Distribution
- Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela.
Product description
CS100 Intra-Aortic Balloon Pump.
Code information (models, lots, serial numbers)
Product number 0998-00-3023-XX: SA122365C8 SA122373C8. International: SA122359C8 SA122375C8 SA122358C8 SA122360C8 SA122363C8 SA122362C8 SA122361C8 SA122368C8 SA147699K8 SA122366C8 SA122370C8 SA119292B8 SA122371C8 SA122364C8 SA122367C8 SA122369C8 SA122372C8.
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
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.
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