Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk
Medical device recall Z-1278-2023. 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
- 669 safety disks 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 Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
669 safety disks, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: DR349559C2 DR352554E2 DR354264F2 DR350872D2 DR351891D2 DR349620C2 DR354572F2 DR353203E2 DR354251F2 DR352588E2 DR352572E2 DR350988D2 DR347950B2 DR348991C2 DR351959D2 DR348566B2 DR353163E2 DR351013D2 DR349563C2 DR352526E2…
Every code shown here, 1,996 characters
Serial Numbers: DR349559C2 DR352554E2 DR354264F2 DR350872D2 DR351891D2 DR349620C2 DR354572F2 DR353203E2 DR354251F2 DR352588E2 DR352572E2 DR350988D2 DR347950B2 DR348991C2 DR351959D2 DR348566B2 DR353163E2 DR351013D2 DR349563C2 DR352526E2 DR351919D2 DR352548E2 DR351927D2 DR344801L1 DR352926E2 DR353698F2 DR352211D2 DR350876D2 DR354556F2 DR350998D2 DR353686F2 DR347941B2 DR354568F2 DR354254F2 DR348987C2 DR353693F2 DR351004D2 DR351330D2 DR348525B2 DR352593E2 DR348530B2 DR351923D2 DR352571E2 DR351907D2 DR351331D2 DR350854D2 DR352589E2 DR347949B2 DR354551F2 DR351872D2 DR350997D2 DR348999C2 DR352537E2 DR351017D2 DR352585E2 DR351403D2 DR350878D2 DR349527C2 DR349558C2 DR352573E2 DR347945B2 DR354244F2 DR352167D2 DR351323D2 DR352199D2 DR352557E2 DR354583F2 DR350863D2 DR348552B2 DR348561B2 DR351376D2 DR353162E2 DR351894D2 DR352192D2 DR354232F2 DR347936B2 DR350994D2 DR345595L1 DR348982C2 DR350867D2 DR351374D2 DR350849D2 DR345642L1 DR354557F2 DR351036D2 DR352591E2 DR353681F2 DR351031D2 DR349568C2 DR352172D2 DR354550F2 DR351358D2 DR354854F2 DR351356D2 DR347959B2 DR348534B2 DR354573F2 DR350873D2 DR352549E2 DR353206E2 DR351320D2 DR351011D2 DR354245F2 DR351368D2 DR353184E2 DR350893D2 DR351379D2 DR351399D2 DR348984C2 DR353190E2 DR351367D2 DR351911D2 DR352565E2 DR348958C2 DR350973D2 DR352567E2 DR349621C2 DR351880D2 DR354243F2 DR348974C2 DR348533B2 DR348988C2 DR348963C2 DR348554B2 DR349590C2 DR353148E2 DR351961D2 DR346935A2 DR352190D2 DR350870D2 DR353177E2 DR352164D2 DR352576E2 DR349578C2 DR348522B2 DR352189D2 DR354257F2 DR345342L1 DR350874D2 DR349575C2 DR348526B2 DR347938B2 DR351395D2 DR353158E2 DR351899D2 DR350869D2 DR354837F2 DR354270F2 DR349515C2 DR354537F2 DR351369D2 DR352529E2 DR350862D2 DR348558B2 DR352181D2 DR351965D2 DR348995C2 DR352566E2 DR353663F2 DR354849F2 DR348540B2 DR350880D2 DR354247F2 DR351409D2 DR350987D2 DR354819F2 DR351377D2 DR351021D2 DR349525C2 DR352168D2 DR350883D2 DR349540C2 DR349617C2 DR349622C2 DR351888D2 DR349544C2 DR352552E2 DR351402D2 DR352580E2 DR349512C2…
FDA’s list runs to 7,374 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 7,374 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.