Datascope Corp. Cardiosave Rescue. Intra-Aortic Balloon Pump system recall: The IFU addendum revises the Preventative Maintenance schedule to align
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
The hazard: Device safety concern
The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
What the notice says: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-0917-2026
- Published
- December 17, 2025
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Datascope Corp.
- Product type
- Medical devices
- Units affected
- 47 units
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Model No. (UDI): 0998-00-0800-83 (10607567108407); ALL SERIAL NO.
- UPC codes
- 10607567108407
Products covered by this recall
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Check your product
The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 10607567108407
Serial number
On the rating plate, often next to the date of manufacture.
- NO. — 47 units
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
Datascope Corp. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
Who pays for a device recall
The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.
- If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
- Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
- If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
- Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.
Company contact: Datascope Corp. — 1300 Macarthur Blvd, Mahwah, NJ, 07430-2052
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Datascope Corp. medical devices recalled?
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 10607567108407. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
Where was the recalled product sold?
It was distributed nationwide.
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