Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO
Medical device recall Z-1042-2022. Published in FDA’s Enforcement Report on May 18, 2022.
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 May 18, 2022. 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
- 6, 035 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 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?
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM04012013P ADM04015013P ADM04015013P ADM04025013P ADM05004013P ADM05004013P ADM05006013P ADM05006013P ADM05008013P ADM05008013P ADM05020013P ADM06004013P ADM06004013P ADM06006013P ADM06006013P ADM06008013P ADM06012013P ADM06015013P ADM06015013P ADM06015013P ADM06015013P ADM07004013P ADM07006013P ADM07006013P ADM07008013P SBI04004013P SBI04008008P SBI04012013P SBI04015013P SBI05004008P SBI05006013P SBI05012008P SBI05012008P SBI05012013P SBI05015013P SBI06004008P SBI06004008P SBI06004013P SBI06004013P SBI06006008P SBI06006008P SBI06008008P SBI06008008P SBI06012013P SBI06012013S SBI06015013P SBI07004013P SBI08004013P SBI08008008S SBI10004008P
6, 035 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number Lot Number GTIN ADM04004013P 0010935559 00643169383500, ADM04008013P 0010935575 00643169383524, ADM04008013P 0010935574 00643169383524, ADM04008013P 0010861910 00643169383524, ADM04012013P 0010968204 00643169383531,…
Every code shown here, 1,989 characters
Model Number Lot Number GTIN ADM04004013P 0010935559 00643169383500, ADM04008013P 0010935575 00643169383524, ADM04008013P 0010935574 00643169383524, ADM04008013P 0010861910 00643169383524, ADM04012013P 0010968204 00643169383531, ADM04015013P 0010891542 00643169576315, ADM04015013P 0010975488 00643169576315, ADM04025013P 0010904889 00643169975064, ADM05004013P 0010861907 00643169383609, ADM05004013P 0010985886 00643169383609, ADM05006013P 0010863869 00643169383616, ADM05006013P 0010954041 00643169383616, ADM05008013P 0010990832 00643169383623, ADM05008013P 0010896018 00643169383623, ADM05020013P 0010904203 00643169975019, ADM06004013P 0010772773 00643169383258, ADM06004013P 0010947006 00643169383258, ADM06006013P 0010968232 00643169383265, ADM06006013P 0010968233 00643169383265, ADM06008013P 0010965798 00643169383272, ADM06012013P 0010891546 00643169859975, ADM06015013P 0010906058 00643169576353, ADM06015013P 0010930866 00643169576353, ADM06015013P 0010900221 00643169576353, ADM06015013P 0010846879 00643169576353, ADM07004013P 0010896015 00643169383340, ADM07006013P 0010863872 00643169383357, ADM07006013P 0010863871 00643169383357, ADM07008013P 0010926488 00643169383364, SBI04004013P 0011018180 00763000366513, SBI04008008P 0010735613 00643169740297, SBI04012013P 0010915831 00763000366605, SBI04015013P 0010947014 00643169740440, SBI05004008P 0010947013 00763000366650, SBI05006013P 0010982240 00763000366698, SBI05012008P 0010742135 00643169740396, SBI05012008P 0010947011 00763000366742, SBI05012013P 0010902109 00643169740402, SBI05015013P 0010863859 00643169740464, SBI06004008P 0010735615 00763000366803, SBI06004008P 0010885373 00763000366803, SBI06004013P 0010894506 00643169740181, SBI06004013P 0011018170 00643169740181, SBI06006008P 0010755363 00763000366834, SBI06006008P 0010982241 00763000366834, SBI06008008P 0010885372 00643169740334, SBI06008008P 0011018176 00643169740334, SBI06012013P 0011029688 00643169740426, SBI06012013S 0010875709 00763000137045,…
FDA’s list runs to 2,188 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 distribution in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, PUERTO RICO, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, Colombia, Croatia Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Republic Of Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Oman, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Russian Federation, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom.
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
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
- 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?
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 Mar 23, 2022.
- FDA classified it on May 6, 2022.
- FDA’s Enforcement Report published it on May 18, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Vascular, Inc., of Santa Rosa, CA.
- 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 2,188 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.