CLASS II ONGOING Device recall · Reported 17 Dec 2025 · FDA Enforcement Report

Cardiosave Rescue recalled by Datascope

Datascope is recalling Cardiosave Rescue, distributed nationwide in the US. The recall was initiated on 4 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. (UDI): 0998-00-0800-83 (10607567108407); ALL SERIAL NO.

Quantity recalled47 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-0917-2026
FDA event ID: 97946
Recalling firm: Datascope, Mahwah, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 4 Nov 2025
FDA classified: 11 Dec 2025
Reported: 17 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

4 Nov 2025	Recall initiated by company
11 Dec 2025	Classified by FDA	+37 days
17 Dec 2025	Published in enforcement report	+6 days

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

Reason for recall

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

Product as listed by the FDA

Cardiosave Rescue. Intra-Aortic Balloon Pump system.

Where it was distributed

Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine Territory, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen, Zambia.

Nationwide

Questions about this recall

Why was it recalled?

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

Which lots are affected?

Model No. (UDI): 0998-00-0800-83 (10607567108407); ALL SERIAL NO.

Where was it sold?

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 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 97946

Reported	Class	Recall	Company	Reason	Where
17 Dec 2025	CLASS II	Cardiosave Hybrid recalled by Datascope	Datascope	Other	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 6,220

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14 Oct 2026Device	CLASS II	TufTex¿ Over-the-Wire Embolectomy Catheter recalled	LeMaitre Vascular	Other	Nationwide
14 Oct 2026Device	CLASS II	Endovascular Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled	Stryker Sustainability Solutions	Particulate Matter	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide