Z-0916-2026Class II

Cardiosave Hybrid. Intra-Aortic Balloon Pump system

Name: Z-0916-2026 Cardiosave Hybrid. Intra-Aortic Balloon Pump system
Creator: Datascope Corp.
Published: 2025-11-04
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2025-11-04 / Open, Classified / root cause: design

FDA source

Datascope Corp. began a recall of Cardiosave Hybrid. Intra-Aortic Balloon Pump system on 2025-11-04. FDA classified it as Class II and gives the reason as "The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0916-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-04
Posted: 2025-12-11
Recalling firm: Datascope Corp.
Product: Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Product code: DSP System, Balloon, Intra-Aortic And Control
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: An 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 commerce: 11,470 units
Distribution: Domestic: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0916-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0916-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11
Z-0917-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11

Product code DSP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)