CLASS I ONGOING Device recall · Reported 6 Sep 2023 · FDA Enforcement Report

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) recalled

Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, distributed nationwide in the US. The recall was initiated on 31 Jul 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449

Quantity recalled9175 units

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-2438-2023
FDA event ID: 92480
Recalling firm: Datascope, Mahwah, NJ
Classification: Class I
Status: Ongoing
Recall initiated: 31 Jul 2023
FDA classified: 30 Aug 2023
Reported: 6 Sep 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

31 Jul 2023	Recall initiated by company
30 Aug 2023	Classified by FDA	+30 days
6 Sep 2023	Published in enforcement report	+7 days

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

Reason for recall

Users were identifying autofill failure conditions on the devices causing pump stops.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Users were identifying autofill failure conditions on the devices causing pump stops.

Which lots are affected?

All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449

Where was it sold?

Worldwide - US Nationwide 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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 92480

Reported	Class	Recall	Company	Reason	Where
6 Sep 2023	CLASS I	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) recalled	Datascope	Device Malfunction	Nationwide

More recalls from Datascope

All 134

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Device	CLASS III	Battery Charging Station recalled by Datascope	Datascope	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	CS100 IABP recalled by Datascope	Datascope	Device Malfunction	Nationwide
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

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide