CS100 IABP. Software Version CS100 IABP Q.01 recallZ-1486-2026 · Datascope Corp. · initiated Jan 23, 2026
Class II Open, Classified All recalls posted in March 2026
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 Corp. 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 firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
FDA root cause category: Under Investigation by firm
What the company is doing
An URGENT MEDICAL DEVICE CORRECTION notice dated January 2026 was mailed to consignees. The notification informs consignees of an updated battery specification to be updated in the IFU. Consignees are to forward the notice to all users in their facility, confirm users are aware of the IFU clarifications, and complete and return the provided Response Form. If product was further distributed, the provided notification is to be forwarded to them. Consignees with any questions should contact Datascope/Getinge Cusotmer Support at 1-888-943-8872, options 4, 2, 1.
Recall details
- Recall number
- Z-1486-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jan 23, 2026
- Posted by the FDA
- Mar 3, 2026
- Recalling firm
- Datascope Corp.
- Quantity
- 10,897 units
- Product code
- DSP
- FDA submissions
- K172305, K031636
- Distribution
- Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador , Estonia, France, Georgia, Germany, Ghana, Greece, Guatemala, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Maldives, Malta, Mauritius, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yemen.
Product description
CS100 IABP. Software Version CS100 IABP Q.01.
Code information (models, lots, serial numbers)
All Model No; All UDI; All Serial No.
Other devices under the same FDA submission
21 devices cleared under K172305, 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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