Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01,…
Medical device recall Z-2835-2020. 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
- 32855 kits 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)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-0470-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
32855 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Kit Lot Number: 3000046316 3000047161 3000047162 3000048615 3000049262 3000049914 3000050929 3000051380 3000052645 3000054090 3000055099 3000056537 3000059946 3000061447 3000062406 3000065986 3000066489 3000066764 3000066770 3000068730…
Every code shown here, 1,500 characters
Kit Lot Number: 3000046316 3000047161 3000047162 3000048615 3000049262 3000049914 3000050929 3000051380 3000052645 3000054090 3000055099 3000056537 3000059946 3000061447 3000062406 3000065986 3000066489 3000066764 3000066770 3000068730 3000069160 3000069376 3000071293 3000071739 3000073191 3000073277 3000074271 3000075134 3000075676 3000076957 3000079650 3000081778 3000084071 3000084788 3000084789 3000086924 3000085291 3000087368 3000088278 3000088570 3000090526 3000090664 3000092443 3000096052 3000097302 3000098997 3000101522 3000103209 3000106823 3000110212 3000111023 3000112113 3000058895 3000064045 3000073190 3000077204 3000084689 3000086162 3000089349 3000094526 3000103212 3000110211 3000046315 3000047053 3000047709 3000048710 3000049479 3000050215 3000050930 3000051379 3000052646 3000054089 3000055098 3000056438 3000060258 3000060259 3000061292 3000063264 3000064522 3000066679 3000065125 3000065984 3000065985 3000066515 3000066680 3000067692 3000069161 3000069872 3000069873 3000071217 3000071891 3000073192 3000074272 3000075133 3000076154 3000076956 3000079648 3000079649 3000080226 3000081779 3000083059 3000084153 3000086058 3000087369 3000088277 3000089284 3000090665 3000092442 3000094528 3000094531 3000096053 3000096054 3000098998 3000098999 3000101523 3000103210 3000106825 3000107337 3000111022 3000112114 3000046411 3000069162 3000069442 3000071837 3000094141 3000111134 3000094151 3000094527 3000096001 3000099000 3000103211 3000106824 3000107336 3000111191 3000112115
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.”
- 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.