Lower riskMedical device recall · FDA · Published May 4, 2023
Datascope Cardiosave IABP Software Update May Not Comply With Safety Standard
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential non-compliance with safety standard 60601-1-12:2014 after a software update.
The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
Datascope is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) with model number 0998-00-0800-55. The recall is because the software update to version D.00 incorrectly stated compliance with a safety standard, which could lead to improper use if the device is not properly regulated. Read more at govinfonow.com/recall/58466-datascope-cardiosave-iabp-software-update-may-not-comply-with-safety.
“Datascope Cardiosave IABP Software Update May Not Comply With Safety Standard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58466-datascope-cardiosave-iabp-software-update-may-not-comply-with-safety. Based on FDA recall #Z-1907-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1907-2023%22&limit=1).
The FDA announced on May 4, 2023, that Datascope Corp. is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps because the digital instructions for use incorrectly annotated compliance to standard 60601-1-12:2014. The recall involves four units distributed in Germany.
Serial Numbers: CB286971I8, CB283804G8, CB283867G8, CB283522G8
The hazard
The digital instructions for use (IFUs) provided with the Cardiosave IABP during a software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
Context
GovInfoNow's records show Datascope Corp. has had 29 other recalls on record since June 17, 2019. Recent similar recalls include a Cardiosave IABP software update needed for safety (Jan. 23, 2026) and a Battery Charging Station recall for a protruding screw (Feb. 6, 2026). Other recent recalls of similar products include Boston Scientific CRT-P Pacemakers requiring a software update (March 19, 2026), Boston Scientific Pacemakers with updated software available (March 19, 2026), and the Philips Cardiac Workstation 7000 risking inaccurate heart rate data (July 1, 2026).
How to tell if you have this one
Check for model number 0998-00-0800-55 on the device. The serial numbers listed are CB286971I8, CB283804G8, CB283867G8, and CB283522G8. The device may also have a UDI-DI code of 10607567108414.
Brand
Datascope
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Verify the model number on the device is 0998-00-0800-55.
Contact Manufacturer
Reach out to Datascope Corp. for further guidance on the recall.
How this recall unfolded
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1907-2023 (May 4, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1907-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.