Affinity Fusion” Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir,…
Medical device recall Z-0826-2017. Published in FDA’s Enforcement Report on Dec 28, 2016.
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 Dec 28, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 21 states named
- 5609 (663 US; 4946 OUS) 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?
Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion¿ Oxygenators with Balance¿1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Affinity Fusion” Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
5609 (663 US; 4946 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product UPN/GTIN Lot Number Product Number 00643169650749 212028376 HY8N22R8 00643169802421 211984809 BB9D23R3 00643169707801 211991294 BB1D41R27 00643169871908 212073806 HY8B75R12 00643169621473 211950617 BB8U95R1 00643169860322 211865249…
Every code shown here, 1,996 characters
Product UPN/GTIN Lot Number Product Number 00643169650749 212028376 HY8N22R8 00643169802421 211984809 BB9D23R3 00643169707801 211991294 BB1D41R27 00643169871908 212073806 HY8B75R12 00643169621473 211950617 BB8U95R1 00643169860322 211865249 BB8E47R15 00643169865365 211975385 BB9D32R2 00643169860322 211991184 BB8E47R15 00643169717336 211991250 BB8Q09R2 00643169792852 211991385 BB9G59R5 00643169740020 211991295 HY8C67R10 00643169649101 211991248 BB7H73R14 00643169868120 212028234 BB8G43R3 00643169860322 212028305 BB8E47R15 00643169873032 212034498 HY9L88R2 00643169534629 212109150 BB7Z44R6 00643169591738 211846477 BB1A19R44 00643169786790 211991196 BB8X02R7 00643169639058 211846421 BB8N94R4 00643169649767 211991286 HY8J73R6 00643169869783 211991482 BB9E16R4 00643169861534 211914227 SSHY9M26R 00643169869516 211974259 BB9L66R 00643169872127 212020797 BB9L72R1 00643169736283 212028295 BB8S37R11 00643169776807 212028317 BB7X32R12 00643169546431 212028362 BB8C09R4 00643169786042 212028304 BB8Y15R1 00643169471597 212028389 BB4W65R13 00643169793699 212073805 BB8C33R6 00643169792036 211846376 BB8N34R5 00643169631649 212021402 BB8T05R1 00643169587106 212073934 HY0W84R28 00643169862920 211991252 HY8H59R17 00643169845121 212073924 BB4B15R13 00643169648111 211885327 BB8A57R11 00643169741720 211804528 BB3M00R29 00643169700284 211807907 HY1F66R18 00643169766839 211957793 BB8D44R4 00643169518131 211957865 HY8B26R4 00643169463929 211885289 BB5Z97R14 00643169714229 211991298 BB7U21R17 00643169617971 211918715 BB4Z62R17 00643169648111 211991256 BB8A57R11 00643169463929 211991381 BB5Z97R14 00643169724457 211892942 BB9B43R2 00643169862036 211951238 BB9H96R 00643169552852 211991198 BB8L58R3 00643169430143 212028385 BB1S56R19 00643169467873 211957783 BB7J04R9 00643169860322 212028306 BB8E47R15 00643169711945 212028358 BB8T77R2 00643169661295 212028419 HY8M65R2 00643169869820 212046220 HY7G33R8 00643169842441 212073804 HY8R55R3 00643169839274 212073871 HY5V41R19 00643169652941 212073987…
FDA’s list runs to 3,478 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) in states of: AK, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, LA, MN, ND, NV, NY, SD, TN, TX, WI, WY and countries of: Canada, Chile, Croatia, Germany, Greece, Hungary, Iran, Italy, Latvia, Lebanon, Poland, Portugal, Romania, Spain, Tanzania, and United Kingdom.
The states and territories these words name
21 states and territories.
Every one of them
- Alaska
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Minnesota
- North Dakota
- Nevada
- New York
- South Dakota
- Tennessee
- Texas
- Wisconsin
- Wyoming
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?
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 Nov 16, 2016.
- FDA classified it on Dec 19, 2016.
- FDA’s Enforcement Report published it on Dec 28, 2016.
- FDA terminated it on Aug 1, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Inc, of Minneapolis, MN.
- 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 3,478 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.