Nico Recalls
7 recalls on record · August 22, 2012 to June 16, 2021 · Medical Devices
Recalls by year
12
15
16
18
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 16, 2021Medical DevicesFDA
Nico Corp. recalls Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection
Hazard: (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some surgical approaches (e.g., endonasal) may increase this potential. {f unintended reduction in light output occurs and/or occlusion of the sleeve is suspected, both the delivery sleeve and the fiber should be replaced (2) Removal for the LX Light Source potential for the distal tip of the sleeve/fiber assembly potential to burn healthy tissue resulting in minor to moderate injury to the patient or end user.
June 16, 2021Medical DevicesFDA
Nico Corp. recalls NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination P
Hazard: (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some surgical approaches (e.g., endonasal) may increase this potential. {f unintended reduction in light output occurs and/or occlusion of the sleeve is suspected, both the delivery sleeve and the fiber should be replaced (2) Removal for the LX Light Source potential for the distal tip of the sleeve/fiber assembly potential to burn healthy tissue resulting in minor to moderate injury to the patient or end user.
August 22, 2018Medical DevicesFDA
Nico Corp. recalls NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
Hazard: Mislabeled hook pouch included a transport/storage label rather than the product label containing key product information such as part number, lot number, and expiration date, etc
June 29, 2016Medical DevicesFDA
Nico Corp. recalls Myriad handpiece Tissue morcellator
Hazard: This recall has been initiated due to a defective component within the handpiece which will cause the handpiece to fail. The failure will result in the inability to cut tissue with the handpiece, rendering it non-functional. Should this failure occur, a replacement Myriad handpiece will be required. If a replacement handpiece is not available, alternate instrumentation for tissue removal will be necessary.
September 23, 2015Medical DevicesFDA
Nico Corp. recalls NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellat
Hazard: Two cables within the console were inadvertently twisted during manufacturing. The individual wires within the cables may break and/or contact one another where the cables terminate into two connectors. When these wires break or contact one another (i.e., short), various types of malfunction may occur with the console. One type of malfunction may result in unexpected aspiration increase.
August 22, 2012Medical DevicesFDA
Nico Corp. recalls 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable
Hazard: BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. This mislabeling was discovered on 29-June-2012 during a clinical case.
August 22, 2012Medical DevicesFDA
Nico Corp. recalls 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable
Hazard: BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. This mislabeling was discovered on 29-June-2012 during a clinical case.