Reported Oct 27, 2021 · Ongoing

Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump…

Datascope Corp.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Datascope Corp. · 1300 Macarthur Blvd · Mahwah, NJ · 07430-2052

Is this the product you have?

3 of 3 products

Products covered by this recall
Model / number	Product as published
—	Model Numbers. 1. Cardiosave Hybrid.
—	Model Numbers: 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. 2. Cardiosave Rescue.
`0998-00-0800-83.`	—

Lot codes and dates: Battery Pack Serial Numbers
131 of 131 codes
192224349IP
191908720IP
202369811IP
202791944IP
191848115IP
192099841IP
192103741IP
192104141IP
171218521PE
181642339PE
202321308IP
191912520IP
191874716IP
191922620IP
181642639PE
192185446IP
171277935PE
192190247IP
202400219IP
202323808IP
191910720IP
181661142PE
192245250IP
202599332IP
181645841PE
181526530PE
202403719IP
181705244PE
192104541IP
191787312IP
181646041PE
191955422IP
202389919IP
191822513IP
191853415IP
192004724IP
192196447IP
192155645IP
202330609IP
171325749PE
192018828IP
191778911IP
192187947IP
192196247IP
181609237PE
192098341IP
191972823IP
191860615IP
202719740IP
202334109IP
202651035IP
191852615IP
192173146IP
202386519IP
202398619IP
202416720IP
202599432IP
191956322IP
192205847IP
192220349IP
Model Number (UDI Number)0998-00-0800-31 (10607567109053), 0998-00-0800-32 (10607567111117), 0998-00-0800-33 (10607567109008), 0998-00-0800-35 (10607567109107), 0998-00-0800-36 (10607567114187), 0998-00-0800-45 (10607567108421), 0998-00-0800-52 (10607567108438), 0998-00-0800-53 (10607567108391), 0998-00-0800-55 (10607567108414), 0998-00-0800-65 (10607567113432), 0998-UC-0800-31 (10607567109053), 0998-UC-0800-33 (10607567109008), 0998-UC-0800-52 (10607567108438), 0998-UC-0800-53 (10607567108391), 0998-UC-0800-55 (10607567108414). 2. Cardiosave Rescue
Model Number0998-00-0800-83 (10607567108407)
Amount recalled: 131 batteries, 11,517 pumps

Where it was sold

Nationwide

Why it was recalled

Stop using this product now

A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Other recalls from Datascope Corp.

Battery Charging Station Mar 25, 2026
CS100 IABP. Software Version CS100 IABP Q.01. Mar 11, 2026
Cardiosave Hybrid Dec 24, 2025
Cardiosave Hybrid. Intra-Aortic Balloon Pump system. Dec 17, 2025
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01 Nov 13, 2024
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to… Oct 2, 2024

20 in total.

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