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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiosave Hybrid IABP

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 Class 2 Device Recall Cardiosave Hybrid IABPsee related information
Date Initiated by FirmNovember 04, 2025
Date PostedDecember 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0916-2026
Recall Event ID 97946
510(K)NumberK112372 K151254 K181122 
Product Classification System, balloon, intra-aortic and control - Product Code DSP
ProductCardiosave Hybrid. Intra-Aortic Balloon Pump system.
Code Information Model No. (UDI): D998-00-0800-31 (10607567109053), D998-00-0800-32 (10607567111117), D998-00-0800-33 (10607567109008), D998-00-0800-35 (10607567109107), D998-00-0800-36 (10607567114187), D998-00-0800-45 (10607567108421), D998-00-0800-52 (10607567108438), D998-00-0800-53 (10607567108391), D998-00-0800-55 (10607567108414), D998-00-0800-65 (10607567113432), D998-UC-0800-31 (10607567109053), D998-UC-0800-33 (10607567109008), D998-UC-0800-52 (10607567108438), D998-UC-0800-53 (10607567108391), D998-UC-0800-55 (10607567108414); ALL SERIAL NO.
Recalling Firm/
Manufacturer		 Datascope Corp.
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information ContactStephanie Howard
201-995-8701
Manufacturer Reason
for Recall		The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
FDA Determined
Cause 2		Component design/selection
ActionAn URGENT MEDICAL DEVICE CORRECTION NOTICE, dated October 2025, was sent via FEDEX to consignees. The notification notifies consignees of four addendum updates: 1) NVRAM Preventive Maintenance (New FSCA - reflected in this recall entry), 2) Vibration and Shock Table Specifications (New FSCA), 3) Helium O-Ring Preventive Maintenance (FSCA 2249723-01/24/2023-004-C), and 4) Battery Runtime Specifications (FSCA 2249723-09/10/2021-001-R). The notification instructs consignees regarding the NVRAM Preventive Maintenance to review the provided IFU addendum, update local preventive maintenance procedures as such, and ensure all NVRAM batteries are within their life expectancy. If a NVRAM is greater than 8 years old, until it can be replaced, it is advised a back-up Cardiosave IABP be available to provide therapy. Consignees with any questions can contact Datascope/Getinge Customer Support at 1-88-943-8872 (options 4, 2, 1) Monday through Friday, from 8:00 AM EST and 6:00 PM EST.
Quantity in Commerce11,470 units
DistributionDomestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine Territory, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen, Zambia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DSP
510(K)s with Product Code = DSP
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