Medtronic tissue stabilizer recalled after tubing was assembled in reverse
Medtronic is recalling one lot of the Octopus Nuvo Tissue Stabilizer after identifying an assembly issue in which the short and long tubes were attached to the wrong ends of the canister.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of a surgical device assembled contrary to its intended design, with no injuries stated in the source.
Plain-English summary
Medtronic Perfusion Systems is recalling the Octopus Nuvo Tissue Stabilizer, a disposable tissue stabilization system, product number TSMICS1. About 2 units were distributed in Florida and Indiana. The FDA has classified this recall as Class II.
During manufacturing, 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.
Affected product carries UDI-DI 00763000543693 and lot number 0232837110.
Facilities can identify affected devices by the product number, UDI and lot number above, and may contact Medtronic Perfusion Systems for further information.
The recalled product
- Product
- Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device — Surgical
- Affected units
- 939
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00763000543693
- Lot Number: 0232837110
Distribution
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