Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01,…
Medical device recall Z-2840-2020. Published in FDA’s Enforcement Report on Sep 2, 2020.
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 Sep 2, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 116652 Kits WW 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?
Potential Endotoxin Contamination
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07, 0684-00-0480-08, 0684-00-0480-10
116652 Kits WW, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Kit Lot Number: 3000046733 3000047274 3000047604 3000048401 3000049310 3000051066 3000051995 3000053048 3000054067 3000054914 3000057090 3000058631 3000059460 3000060261 3000060731 3000060848 3000062743 3000064057 3000071409 3000065401…
Every code shown here, 1,996 characters
Kit Lot Number: 3000046733 3000047274 3000047604 3000048401 3000049310 3000051066 3000051995 3000053048 3000054067 3000054914 3000057090 3000058631 3000059460 3000060261 3000060731 3000060848 3000062743 3000064057 3000071409 3000065401 3000065942 3000066768 3000067500 3000068688 3000068689 3000070070 3000072315 3000072885 3000083860 3000075682 3000076775 3000079570 3000080053 3000077520 3000077941 3000078503 3000078600 3000078656 3000079242 3000080764 3000081888 3000082186 3000082885 3000083861 3000084565 3000084851 3000085193 3000087974 3000088594 3000088639 3000089730 3000090853 3000091126 3000091327 3000092503 3000093663 3000095290 3000095946 3000096738 3000097654 3000099417 3000100344 3000101784 3000103915 3000105898 3000106317 3000109026 3000111350 3000111973 3000048959 3000047353 3000047706 3000048026 3000048961 3000048960 3000048962 3000050258 3000051647 3000052948 3000054290 3000054291 3000054967 3000056074 3000057384 3000058896 3000058897 3000060262 3000060733 3000063082 3000063083 3000064046 3000066141 3000066142 3000066284 3000067688 3000069656 3000069657 3000070408 3000070664 3000071058 3000071414 3000073065 3000073403 3000075684 3000079569 3000080103 3000077273 3000077519 3000078683 3000080104 3000080443 3000080782 3000082659 3000083600 3000085381 3000086267 3000087315 3000089459 3000090849 3000092396 3000093113 3000094005 3000095038 3000095945 3000098249 3000100378 3000102536 3000103919 3000106447 3000109023 3000110738 3000115116 3000116665 3000047198 3000047708 3000049208 3000049723 3000051122 3000052154 3000052155 3000053152 3000053792 3000054880 3000056191 3000056936 3000057345 3000058847 3000060260 3000060587 3000063258 3000064097 3000065030 3000065853 3000065943 3000066282 3000067497 3000068770 3000069317 3000070409 3000070410 3000071410 3000072886 3000072916 3000075681 3000076776 3000075131 3000079466 3000080054 3000077522 3000077523 3000077524 3000078051 3000078684 3000080537 3000080783 3000081157 3000083094 3000083092 3000083093 3000080538…
FDA’s list runs to 4,327 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.
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Jul 27, 2020.
- FDA classified it on Aug 21, 2020.
- FDA’s Enforcement Report published it on Sep 2, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Datascope Corporation, of Fairfield, 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 4,327 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
-
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.