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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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,
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Vascular, Inc.
- Reason for Recall:
- Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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
Product Codes/Lot Numbers:
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,
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1042-2022
Related Recalls
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Medtronic Vascular
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.
Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.