FDA (Devices) recall action 98966
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medtronic Perfusion Systems is recalling the Octopus Evolution Tissue Stabilizer, Model TS2000, due to an assembly error where tubing was incorrectly positioned during manufacturing.
Medtronic is recalling 590 units of the Octopus 4 Tissue Stabilizer, Model 29400 due to an assembly error where tubing was attached to the wrong positions during manufacturing.
Medtronic is recalling 288 units of the Octopus Evolution AS Tissue Stabilizer Model TS2500 due to incorrect tubing positioning during manufacturing, where short and long tubes were attached to wrong locations.