FDA-Device2024-05-22Class II
Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers: 31200
Hazard
Potential for unsealed sterile packing.
Sold states
Worldwide distribution.
Affected count
1410 units
Manufactured in
7611 Northland Dr N, N/A, Brooklyn Park, MN, United States
Products
Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers: 31200
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1803-2024More Medtronic Perfusion Systems recalls
- FDA-Device2026-07-22Medtronic Bio-Medicus Adult Cannula Kit recalled for loose foreign material with blood
- FDA-Device2026-07-22Medtronic DLP One-Piece Pediatric Arterial Cannula recalled for loose foreign material with blood
- FDA-Device2026-07-01Medtronic Octopus Evolution AS Tissue Stabilizer recalled for reversed tubing assembly
- FDA-Device2026-07-01Medtronic Octopus 4 Tissue Stabilizer recalled for reversed tubing assembly
- FDA-Device2026-07-01Medtronic Octopus Evolution Tissue Stabilizer recalled for incorrect tubing assembly
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