Recall Z-1042-2022— Medtronic Vascular, Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic Vascular, Inc., initiated 2022-03-23. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Packaging for Balloon Catheters may be damaged resulting in loss of sterility..
- Recalling firm
- Medtronic Vascular, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-23
- Firm location
- Santa Rosa, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.