CLASS II ONGOING Device recall · Reported 15 Mar 2023 · FDA Enforcement Report

Cardiosave Rescue recalled by Datascope

Datascope is recalling Cardiosave Rescue, distributed nationwide in the US. The recall was initiated on 7 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 0998-00-0800-83. UDI-DI: 10607567108407. All serial numbers.

Quantity recalled47 units (44 US, 3 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1232-2023
FDA event ID: 91642
Recalling firm: Datascope, Mahwah, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 7 Feb 2023
FDA classified: 6 Mar 2023
Reported: 15 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

7 Feb 2023	Recall initiated by company
6 Mar 2023	Classified by FDA	+27 days
15 Mar 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

Nationwide US distribution. Worldwide international distribution.

Nationwide

Questions about this recall

Is Cardiosave Rescue recalled?

Yes. Datascope recalled Cardiosave Rescue on 7 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1232-2023.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Nationwide US distribution. Worldwide international distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Datascope

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Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Device	CLASS III	Battery Charging Station recalled by Datascope	Datascope	Device Malfunction	Nationwide
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11 Mar 2026Device	CLASS II	CS300 IABP recalled by Datascope	Datascope	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS III	Cardiosave Hybrid recalled by Datascope	Datascope	Other	Nationwide
24 Dec 2025Device	CLASS III	Cardiosave Rescue recalled by Datascope	Datascope	Other	Nationwide

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