Class III U.S. Food and Drug Administration

Datascope Corp. Cardiosave Hybrid recall: The IFU addendum updates the Vibration and Shock Table to reference

Recall published 10 months ago

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

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 updates the Vibration and Shock Table to reference the correct standards.

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-0931-2026
Published
December 24, 2025
Risk level
Class III
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Datascope Corp.
Product type
Medical devices
Units affected
11470 units (5095 US, 6375 OUS)
Distribution
Nationwide
Made in
United States
Lot / code info
1) Model: 0998-00-0800-31; UDI-DI: 10607567109053; Serial Numbers: All; 2) Model: 0998-00-0800-32; UDI-DI: 10607567111117; Serial Numbers: All; 3) Model: 0998-00-0800-33; UDI-DI: 10607567109008; Serial Numbers: All; 4)Model: 0998-00-0800-35; UDI-DI: 10607567109107; Serial Numbers: All; 5)Model: 0998-00-0800-36; UDI-DI: 10607567114187; Serial Numbers: All; 6)Model: 0998-00-0800-45; UDI-DI: 10607567108421; Serial Numbers: All; 7)Model: 0998-00-0800-52; UDI-DI: 10607567108438; Serial Numbers: All; 8)Model: 0998-00-0800-53; UDI-DI: 10607567108391; Serial Numbers: All; 9) Model: 0998-00-0800-55; UDI-DI: 10607567108414; Serial Numbers: All; 10) Model: 0998-00-0800-65; UDI-DI: 10607567113432; Serial Numbers: All; 11) Model: 0998-UC-0800-31; UDI-DI: 10607567109053; Serial Numbers: All; 12) Model: 0998-UC-0800-33; UDI-DI: 10607567109008; Serial Numbers: All; 13) Model: 0998-UC-0800-52; UDI-DI: 10607567108438; Serial Numbers: All; 14) Model: 0998-UC-0800-53; UDI-DI: 10607567108391; Serial Numbers: All; 15) Model: 0998-UC-0800-55; UDI-DI: 10607567108414; Serial Numbers: All;
UPC codes
10607567109053, 10607567111117, 10607567109008, 10607567109107, 10607567114187, 10607567108421, 10607567108438, 10607567108391, 10607567108414, 10607567113432

Products covered by this recall

Cardiosave Hybrid

Check your product

The notice names 25 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.

  • 10607567109053
  • 10607567111117
  • 10607567109008
  • 10607567109107
  • 10607567114187
  • 10607567108421
  • 10607567108438
  • 10607567108391
  • 10607567108414
  • 10607567113432

Model or item number

On the rating label, the box or the instruction sheet.

  • 0998-00-0800-31
  • 0998-00-0800-32
  • 0998-00-0800-33
  • 0998-00-0800-35
  • 0998-00-0800-36
  • 0998-00-0800-45
  • 0998-00-0800-52
  • 0998-00-0800-53
  • 0998-00-0800-55
  • 0998-00-0800-65
  • 0998-UC-0800-31
  • 0998-UC-0800-33
  • 0998-UC-0800-52
  • 0998-UC-0800-53
  • 0998-UC-0800-55

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.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. 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 updates the Vibration and Shock Table to reference the correct standards. The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10607567109053, 10607567111117, 10607567109008; model number 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33. 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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