Ninepoint Medical Inc.: Medical Device Recall in 2018 - (Recall #: Z-1781-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)005275) Product Usage: The NvisionVLE Low-Profile Optical Probe is intended to be used for imaging the micro-structure of human tissue. When used with the NvisionVLE Imaging System it provides two-dimensional, cross-sectional, real-time depth visualization.

Product Classification:

Class II

Date Initiated: April 11, 2018

Date Posted: May 16, 2018

Recall Number: Z-1781-2018

Event ID: 79884

Reason for Recall:

Distal tips of the probes may detach from the probe shaft during use.

Status: Terminated

Product Quantity: 152

Code Information:

Lot Numbers: 005196, 005251, 005275

Distribution Pattern:

US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, MA, NJ, NM, NY, TX

Voluntary or Mandated:

Voluntary: Firm initiated