Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A…
Medical device recall Z-0293-2018. Published in FDA’s Enforcement Report on Jan 17, 2018.
- 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 Jan 17, 2018. 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
- 1730 units 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 component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA) or transaortic (TAo) approach to transcatheter aortic valve replacement.
1730 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Numbers: 60677653 60703356 60703356 60733369 60898859 60708907 60708907 60693311 60677343 60678033 60708907 60699067 60685057 60712982 60760615 60792834 60776987 60813952 60782083 60796436 60840392 60842807 60854965 60885861 60930443…
Every code shown here, 1,993 characters
Lot Numbers: 60677653 60703356 60703356 60733369 60898859 60708907 60708907 60693311 60677343 60678033 60708907 60699067 60685057 60712982 60760615 60792834 60776987 60813952 60782083 60796436 60840392 60842807 60854965 60885861 60930443 60677270 60678035 60678040 60703355 60704423 60703355 60704423 60679106 60689105 60718006 60718007 60792838 60813951 60782088 60816613 60816614 60842808 60842810 60873492 60842809 60885862 60885863 60930444 60697333 60703357 60703357 60678007 60739663 60733367 60733366 60760822 60801453 60808313 60776988 60816615 60883652 60842811 60739661 60718977 60718978 60718979 60724851 60724852 60724853 60724854 60724855 60724856 60724857 60724858 60724859 60724860 60724861 60724862 60724863 60724864 60724865 60724866 60724867 60724868 60724869 60724870 60730280 60730282 60730283 60730284 60730285 60730286 60730287 60730288 60730318 60730289 60730319 60730320 60730321 60735835 60735836 60735789 60735790 60735791 60735792 60735793 60735794 60737235 60737236 60739823 60739824 60744633 60744634 60744636 60744637 60744638 60744635 60744823 60744824 60744825 60745017 60745016 60746726 60746727 60746728 60746729 60746730 60746731 60748826 60748827 60748828 60748829 60748831 60748832 60749200 60749201 60749214 60749213 60750611 60750612 60751302 60751303 60753189 60753192 60753191 60753190 60754451 60754452 60756176 60756177 60756487 60756488 60757572 60758167 60758168 60758169 60758170 60758183 60758184 60757932 60757931 60757766 60757765 60757573 60757976 60757975 60759299 60759300 60759485 60759486 60759588 60759589 60759704 60759705 60760609 60760610 60760901 60760902 60760903 60760904 60760905 60760906 60761419 60761420 60761421 60761422 60763201 60763206 60763207 60763202 60764509 60764510 60764511 60764512 60764532 60764533 60764640 60764641 60764647 60764648 60764725 60764726 60764615 60764616 60764604 60764605 60764733 60764734 60764785 60764786 60764787 60764788 60764812 60764813 60764814 60764815 60764818 60764819 60766845 60766846…
FDA’s list runs to 16,284 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.
United States: All states with the exception of: Alaska, Hawaii, Idaho, New Mexico, Rhode Island, South Dakota and Wyoming
These words name no state.
They leave out Alaska, Hawaii, Idaho, New Mexico, Rhode Island, South Dakota and Wyoming.
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 Jul 21, 2017.
- FDA classified it on Jan 10, 2018.
- FDA’s Enforcement Report published it on Jan 17, 2018.
- FDA terminated it on Sep 13, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Edwards Lifesciences, LLC, of Draper, UT.
- 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 16,284 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.