The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE…
Medical device recall Z-1108-2023. Published in FDA’s Enforcement Report on Feb 15, 2023.
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 Feb 15, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 49 states named
- 10,815 devices (U.S. 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 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?
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.
10,815 devices (U.S. total), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Catalog Numbers/UDI Codes/Lot_Serial Numbers: AVFM06040 (01)00801741106422(17)230806(10)ANFV0313 (01)00801741106422(17)231105(10)ANFY0615 (01)00801741106422(17)231112(10)ANFY1670 ANFV0313 ANFY0615 ANFY1670 AVFM06080…
Every code shown here, 1,995 characters
Catalog Numbers/UDI Codes/Lot_Serial Numbers: AVFM06040 (01)00801741106422(17)230806(10)ANFV0313 (01)00801741106422(17)231105(10)ANFY0615 (01)00801741106422(17)231112(10)ANFY1670 ANFV0313 ANFY0615 ANFY1670 AVFM06080 (01)00801741106446(17)231001(10)ANFX0083 ANFX0083 AVFM06100 (01)00801741106453(17)230625(10)ANFT3586 (01)00801741106453(17)230924(10)ANFW3143 ANFT3586 ANFW3143 AVFM07040 (01)00801741106460(17)230618(10)ANFT2594 (01)00801741106460(17)230728(10)ANFU3611 (01)00801741106460(17)230804(10)ANFV0172 (01)00801741106460(17)231101(10)ANFY0004 (01)00801741106460(17)231105(10)ANFY0616 ANFT2594 ANFU3611 ANFV0172 ANFY0004 ANFY0616 AVFM07060 (01)00801741106477(17)230611(10)ANFT1469 (01)00801741106477(17)230618(10)ANFT2644 (01)00801741106477(17)230702(10)ANFU0185 (01)00801741106477(17)230709(10)ANFU1105 (01)00801741106477(17)230722(10)ANFU2677 (01)00801741106477(17)230804(10)ANFV0168 (01)00801741106477(17)230809(10)ANFV0764 (01)00801741106477(17)230809(10)ANFV0844 (01)00801741106477(17)231007(10)ANFX1081 (01)00801741106477(17)231026(10)ANFX3588 (01)00801741106477(17)231029(10)ANFX4098 ANFT1469 ANFT2644 ANFU0185 ANFU1105 ANFU2677 ANFV0168 ANFV0764 ANFV0844 ANFX1081 ANFX3588 ANFX4098 AVFM07080 (01)00801741106484(17)230611(10)ANFT1470 (01)00801741106484(17)230722(10)ANFU2678 (01)00801741106484(17)231103(10)ANFY0162 (01)00801741106484(17)231105(10)ANFY0655 ANFT1470 ANFU2678 ANFY0162 ANFY0655 AVFM07100 (01)00801741106491(17)230722(10)ANFU2681 (01)00801741106491(17)230917(10)ANFW2013 (01)00801741106491(17)231029(10)ANFX4135 (01)00801741106491(17)231112(10)ANFY1672 ANFU2681 ANFW2013 ANFX4135 ANFY1672 AVFM08040 (01)00801741106507(17)230604(10)ANFT0451 (01)00801741106507(17)230611(10)ANFT1471 (01)00801741106507(17)230618(10)ANFT2595 (01)00801741106507(17)230702(10)ANFU0186 (01)00801741106507(17)230716(10)ANFU2274 (01)00801741106507(17)230721(10)ANFU2533 (01)00801741106507(17)230804(10)ANFV0169 (01)00801741106507(17)230804(10)ANFV0174 (01)00801741106507(17)230809(10)ANFV0765…
FDA’s list runs to 31,175 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 - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, WI, and WV the country of Canada.
The states and territories these words name
49 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Guam
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
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 Dec 22, 2022.
- FDA classified it on Feb 9, 2023.
- FDA’s Enforcement Report published it on Feb 15, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Bard Peripheral Vascular Inc, of Tempe, AZ.
- 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 31,175 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.