Ninepoint Medical Recalls NvisionVLE Low-Profile Optical Probes
Ninepoint Medical is recalling 152 NvisionVLE Low-Profile Optical Probes because the distal tips may detach from the probe shaft during use.
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 is classified as FDA Class II, and the hazard involves a mechanical defect (detachment of distal tips) in a medical device used on human tissue, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Ninepoint Medical Inc. is recalling 152 units of the NvisionVLE Low-Profile Optical Probe, catalog numbers 95501-LP and 95501-LP-5. The affected units are identified by lot numbers 005196, 005251, and 005275. The recall is classified as Class II by the FDA.
The recall was initiated because the distal tips of the probes may detach from the probe shaft during use. The product is intended for imaging the micro-structure of human tissue and provides two-dimensional, cross-sectional, real-time depth visualization when used with the NvisionVLE Imaging System.
The affected units were distributed nationwide in the states of Alabama, Arizona, California, Florida, Georgia, Illinois, Massachusetts, New Jersey, New Mexico, New York, and Texas. No specific instructions for consumers are provided in the source text, but the hazard involves potential component detachment during medical imaging procedures.
The recalled product
- Product
- 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…
- Manufacturer
- Ninepoint Medical Inc.
- Category
- Medical Device — Imaging Probe
- Affected units
- 152
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 (3)
- Lot Numbers: 005196
- 005251
- 005275
Distribution
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