FDA-Device2021-10-13Class II
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Hazard
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Sold states
Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.
Affected count
168 kits
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0003-2022More 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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