Medtronic IN.PACT AV Balloon Catheter Recall: Packaging Risk of Sterility Loss
Medtronic recalls Paclitaxel-coated PTA balloon catheters with packaging that may lose sterility, risking infection during procedures. Affected units include specific lot numbers and model codes.
Lower-risk recall
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Contact the company
What happened, in plain English
Medtronic is recalling Paclitaxel-coated PTA balloon catheters that may have damaged packaging, leading to loss of sterility. This could cause infections during medical procedures if the catheter is used without proper sterility. Read more at govinfonow.com/recall/60900-medtronic-in-pact-av-balloon-catheter-recall-packaging-risk-of.
Source Summary by GovInfoNow · govinfonow.com/recall/60900-medtronic-in-pact-av-balloon-catheter-recall-packaging-risk-of · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1043-2022
Cite this page
“Medtronic IN.PACT AV Balloon Catheter Recall: Packaging Risk of Sterility Loss.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/60900-medtronic-in-pact-av-balloon-catheter-recall-packaging-risk-of. Based on FDA recall #Z-1043-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1043-2022%22&limit=1).
Why it’s dangerous
Damaged packaging could allow contamination, leading to loss of sterility. This might cause infections during medical procedures if the catheter is used without proper sterility.
Who’s affected
Healthcare professionals using the Medtronic IN.PACT AV catheter for procedures. Patients receiving the catheter during medical treatments are at risk if the packaging is compromised.
How to tell if you have this one
Check for the lot number 0010990608 and GTIN 00763000232580 on the packaging. The product is a Paclitaxel-coated PTA balloon catheter with the reference code IAV06008008P.
- Brand
Medtronic- Product
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1042-2022 | 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; 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, SBI06015013P 0010745656 00643169740488, SBI07004013P 0010926502 00643169740204, SBI08004013P 0010742136 00643169777712, SBI08008008S 0010864424 00763000136857, SBI10004008P 0010915833 00643169777880, | 6, 035 units |
| Z-1043-2022 | Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only; Lot Number: 0010990608/ GTIN: 00763000232580 | 3 units |
What to do — step by step
Check Packaging Integrity
Inspect the packaging for signs of damage that could compromise sterility.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 47 states.
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: 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.
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1043-2022 (March 23, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1043-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.