Home/Recalls/FDA-Z-1473-2026
FDA DevicesClass II

Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

Published: March 4, 2026Recall ID: Z-1473-2026Category: devicesCountry: US
US
Medical DeviceFDA DevicesUSUS

Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

Recalling Firm: Medtronic Perfusion Systems

Reason for Recall / Hazard

During the 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.

Product Description & Identification

Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

Additional Source Details

FieldValue
CityBrooklyn Park
StateMN
Event id98354
Address 17611 Northland Dr N
Address 2N/A
Code infoUDI-DI: 00763000543693; Lot Number: 0232837110, Additional lots as of 5/22/26: 0231547054 0231591827 0231758880 0231758898 0231758932 0231792414 0231792421 0231912903 0232670901 0232709219 0232709254 0232744928 0232784925 0232784989 0232805458
Postal code55428-1088
Report date20260304
Product typeDevices
Product quantity939 units
Reason for recallDuring the 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.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260113
Initial firm notificationLetter
Center classification date20260226

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Overview

  • Recalling FirmMedtronic Perfusion Systems
  • StatusOngoing
  • Risk LevelClass II
  • DistributionUS Nationwide. Global Distribution.
Recall Hazard Severity
High Alert (Class I)
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