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Cardiosave Rescue. Model Number: 0998-00-0800-83 recallZ-1232-2023 · Datascope Corp. · initiated Feb 7, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Datascope Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.

FDA root cause category: Equipment maintenance

What the company is doing

Firm notified customers on February 7, 2023, in an Urgent Medical Device Correction letter which discussed four issues in total - this issue was Issue #4. Customers were instructed to contact their Datascope/Getinge service representative if they observe any visual damage to the O-ring installed as part of the quick disconnect fitting. Datascope/Getinge is currently updating the annual Preventive Maintenance instruction to include replacement of the quick disconnect fitting O-ring. If you have any questions, please contact your Datascope/Getinge representative or call the Datascope/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). On 11/04/2025 the recall was expanded, and consignees were notified via letter. The notification was for awareness to the update of Datascope s preventative maintenance in the IFU addendum, which was provided to consignees. The IFU Addendum contains an updated Schedule B Preventive Maintenance Schedule which calls for the Quick Disconnect Fitting O-Ring to be replaced and to lubricate the console release latch every 12 months or 2500 hours. The Service Manual has contained this update to Preventive Maintenance for the Helium O-Ring since June 2023. Consignees were instructed to review the IFU Addendum and local Preventive Maintenance Schedule and update their Preventive Maintenance schedule accordingly.

Recall details

Recall number
Z-1232-2023
Status
Open, Classified
Initiated by the company
Feb 7, 2023
Posted by the FDA
Mar 6, 2023
Recalling firm
Datascope Corp.
Quantity
47 units (44 US, 3 OUS)
Product code
DSP
FDA submissions
K181122
Distribution
Nationwide US distribution. Worldwide international distribution.

Product description

Cardiosave Rescue. Model Number: 0998-00-0800-83.

Code information (models, lots, serial numbers)

Model Number: 0998-00-0800-83. UDI-DI: 10607567108407. All serial numbers.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 91642).

Sources and updates

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