Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2
Medical device recall Z-2408-2020. Published in FDA’s Enforcement Report on Jul 8, 2020.
- FDA Class I
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 Jul 8, 2020. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 2123 total 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
2123 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial number ranges: Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 140868V 140901V through 140909V 140914V through 140920V 150102V 150106V through 150107V 150110V through 150113V 150115V through 150116V 150220V 150401V…
Every code shown here, 1,997 characters
Serial number ranges: Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 140868V 140901V through 140909V 140914V through 140920V 150102V 150106V through 150107V 150110V through 150113V 150115V through 150116V 150220V 150401V 150407V 150409V 150507V through 150513V 150601V through 150605V 150608V through 150611V 150625V 150702V through 150705V 150707V 150720V 150801V through 150802V 150821V 150824V 150827V through 150830V 150901V through 150906V 150908V through 150912V 150919V through 150923V 150925V through 150939V 151009V through 151013V 151015V through 151016V 151019V 151021V through 151027V 151029V 151102V through 151103V 151105V 151108V 151111V 151113V 151201V through 151208V 151210V through 151212V 151214V through 151218V Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 151220V 160101V through 160103V 160105V through 160109V 160112V through 160118V 160120V 160122V 160126V 160201V through 160209V 160211V 160213V through 160214V 160216V through 160217V 160219V 160312V through 160314V 160316V through 160323V 160325V through 160327V 160331V 160401V through 160410V 160412V 160418V through 160422V 160519V 160525V 160529V through 160530V 160605V 160614V 160618V 160630V 160638V through 160639V 160645V 160703V 160718V 160720V 160726V 160728V through 160730V 170101V through 170110V 170401V through 170410V 170501V through 170520V 170601V through 170625V 170811V through 170830V 171021V through 171030V 171037V through 171046V 171106V through 171115V 180131V through 180150V Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 180211V through 180230V 180411V through 180420V 180441V through 180450V 180521V through 180530V 180621V through 180630V 180711V through 180720V 180741V through 180750V 180811V through 180820V 181011V through 181040V 181111V through 181130V 190121V through 190130V 190141V through 190150V 190211V through 190220V 190411V through 190420V 190431V through 190440V 190531V through 190540V 190701V through 190712V 190737V through…
FDA’s list runs to 2,244 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.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 May 20, 2020.
- FDA classified it on Jun 26, 2020.
- FDA’s Enforcement Report published it on Jul 8, 2020.
- FDA terminated it on Jan 7, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Arrow International Inc, of Reading, PA.
- 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 2,244 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.