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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic IN.PACT Admiral, Paclitaxelcoated PTA Balloon Catheter

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  Class 2 Device Recall Medtronic IN.PACT Admiral, Paclitaxelcoated PTA Balloon Catheter see related information
Date Initiated by Firm March 23, 2022
Create Date May 06, 2022
Recall Status1 Open3, Classified
Recall Number Z-1042-2022
Recall Event ID 89935
PMA Number P140010 
Product Classification Drug-Eluting Peripheral Transluminal Angioplasty Catheter - Product Code ONU
Product 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
Code Information 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.
Recalling Firm/
Manufacturer		 Medtronic Vascular, Inc.
3576 Unocal Pl
Santa Rosa CA 95403-1774
For Additional Information Contact Medtronic Vascular Customer Service
800-716-6700
Manufacturer Reason
for Recall		 Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
FDA Determined
Cause 2		 Packaging process control
Action On March 23, 2022 Medtronic issued a "Urgent: Medical Device Recall" notification to affected consignees. In addition to informing consignees about the recalled product, Medtronic ask consignees to take the following actions: 1. Identify and quarantine all unused affected IN.PACT Admiral and IN.PACT AV catheters as listed in Table 1. 2. Return all unused affected product in your inventory to Medtronic. Contact Medtronic Vascular Customer Service at 800-716-6700 to initiate a product return. Your local Medtronic Representative can assist you with the initiation of the return. 3. Please complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. 4. This notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = ONU and Original Applicant = MEDTRONIC Inc.
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