Nico Myriad Console Recalled for Potential Cable Malfunction
Nico Corp. is recalling six Myriad Console units because twisted cables may cause wire breaks or shorts, leading to unexpected aspiration increases during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a medical device with a defect that can cause malfunction (unexpected aspiration increase) during surgery. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Nico Corp. is recalling six units of the NICO Myriad Console, model number NN-7000. The Myriad System is a surgical device designed for the morcellation and removal of soft tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures. The specific units affected have serial numbers 00231, 00232, 00242, 00245, 00248, and 00250.
The recall was initiated because two cables within the console were inadvertently twisted during manufacturing. This defect may cause the individual wires within the cables to break or contact one another where the cables terminate into connectors. Such wire breaks or short circuits can result in various types of console malfunction, including an unexpected increase in aspiration.
The affected units were distributed in the United States to the states of Maryland, Indiana, California, and North Carolina. Users of these devices should contact Nico Corp. for further instructions regarding the recall and replacement of the affected consoles.
The recalled product
- Product
- NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue…
- Manufacturer
- Nico Corp.
- Affected units
- 6
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 (6)
- Model number NN-7000 SN: 00231
- 00232
- 00242
- 00245
- 00248
- 00250
Distribution
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