Severity
Moderate
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 S
Reported: May 18, 2022 Initiated: March 23, 2022 #Z-1042-2022 6, 035 units units
Medtronic Vascular, Inc. issued this FDA Devices recall on May 18, 2022. Classified as Moderate severity (Class II). Approximately 6, 035 units units are affected. The recall was issued because: Packaging for Balloon Catheters may be damaged resulting in loss of sterility.. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-1042-2022) was formally reported on May 18, 2022, with the manufacturer initiating the action on March 23, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic Vascular, Inc. is listed as the recalling firm, operating out of Santa Rosa, CA. Federal records indicate 6, 035 units units are affected.
The documented reason for this recall is: Packaging for Balloon Catheters may be damaged resulting in loss of sterility. Distribution data in the federal record shows the product reached: 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, Ind…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
6, 035 units
Related Recalls
6
6 from same agency
Product Description
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
Reason for Recall
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Details
- Recalling Firm
- Medtronic Vascular, Inc.
- Units Affected
- 6, 035 units
- 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.
- Location
- Santa Rosa, CA
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1042-2022 |
| Date reported | May 18, 2022 |
| Date initiated | March 23, 2022 |
| Recalling firm | Medtronic Vascular, Inc. |
| Units affected | 6, 035 units |
| 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, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was 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. Recalled by Medtronic Vascular, Inc.. Units affected: 6, 035 units.
Why was this product recalled? ▼
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2022. Severity: Moderate. Recall number: Z-1042-2022.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1042-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).