Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP)
Medical device recall Z-1276-2023. Published in FDA’s Enforcement Report on Mar 29, 2023.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 29, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 391 total IABPs how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, and 0998-00-0800-65
391 total IABPs, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number: 0998-00-0800-31, UDI-DI: 10607567109053; Model Number: 0998-00-0800-32, UDI-DI: 10607567111117; Model Number: 0998-00-0800-33, UDI-DI: 10607567109008; Model Number: 0998-00-0800-35, UDI-DI: 10607567109107; Model Number:…
Every code shown here, 2,000 characters
Model Number: 0998-00-0800-31, UDI-DI: 10607567109053; Model Number: 0998-00-0800-32, UDI-DI: 10607567111117; Model Number: 0998-00-0800-33, UDI-DI: 10607567109008; Model Number: 0998-00-0800-35, UDI-DI: 10607567109107; Model Number: 0998-00-0800-45, UDI-DI: 10607567108421; Model Number: 0998-00-0800-52, UDI-DI: 10607567108438; Model Number: 0998-00-0800-53, UDI-DI: 10607567108391; Model Number: 0998-00-0800-55, UDI-DI: 10607567108414; Model Number: 0998-00-0800-65, UDI-DI: 10607567113432; Serial Numbers: CB355244F2, CB355245F2, CB356759G2, CB356760G2, CB351303D2 CB355431F2 CB355432F2 CB355433F2 CB355434F2 CB355435F2 CB356761G2 CB356762G2 CB356763G2 CB356764G2 CB356765G2 CB351313D2 CB352952E2 CB352953E2 CB355240F2 CB355241F2 CB355242F2 CB355243F2 CB356766G2 CB356767G2 CB356768G2 CB356769G2 CB356770G2 CH351787D2 CH352224D2 CH352225D2 CH352228D2 CH352280E2 CH352283E2 CH352284E2 CH352287E2 CH352289E2 CH352290E2 CH352297E2 CH352298E2 CH353439E2 CH353443E2 CH353445E2 CH353448E2 CH353451E2 CH353454E2 CH353795F2 CH353796F2 CH353797F2 CH353798F2 CH353799F2 CH353801F2 CH353802F2 CH353803F2 CH353804F2 CH353805F2 CH353806F2 CH353807F2 CH353808F2 CH353809F2 CH353810F2 CH353811F2 CH353812F2 CH353813F2 CH353814F2 CH354143F2 CH354144F2 CH354145F2 CH354146F2 CH354147F2 CH354148F2 CH354149F2 CH354150F2 CH354151F2 CH354152F2 CH354153F2 CH354154F2 CH354155F2 CH354156F2 CH354157F2 CH354158F2 CH354159F2 CH354160F2 CH354161F2 CH354162F2 CB351043D2 CB351792D2 CB352956E2 CB353456E2 CB354411F2 CB354412F2 CB354413F2 CB354414F2 CB354415F2 CB354416F2 CB354417F2 CB354418F2 CB354419F2 CB355239F2 CB356772G2 CB356773G2 CB356774G2 CB356775G2 CB356776G2 CA209023D2 CH257564F7 CH352970E2 CH355589F2 CA211084E2 CH257750F7 CH352973E2 CH355590F2 CA212105F2 CH260122H7 CH352975E2 CH355591F2 CA212724F2 CH260980H7 CH352976E2 CH355592F2 CA213851G2 CH261704H7 CH352979E2 CH355593F2 CA214935H2 CH263200I7 CH352981E2 CH355594F2 CA216307I2 CH263202I7 CH352983E2 CH355595F2 CA217776J2 CH263207I7 CH352986E2 CH355596F2…
FDA’s list runs to 4,793 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Distribution list not yet provided.
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 28, 2023.
- FDA classified it on Mar 22, 2023.
- FDA’s Enforcement Report published it on Mar 29, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Datascope Corp., of Mahwah, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,793 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.