Recall record at a glance
| Official record | Z-1042-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Medtronic Vascular, Inc. |
| Report date | May 18, 2022 |
| Recall initiation date | Mar 23, 2022 |
| Quantity | 6, 035 units |
| Location | Santa Rosa, CA, United States |
Official 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
Why the product was recalled
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Distribution information
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 to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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