Aesculap Minop InVent 30 Trocar System Recalled for Sharp Edges
Aesculap Implant Systems LLC is recalling the Minop InVent 30 Trocar System because sharp edges may abrade insulation 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 involves a medical device with a potential for physical injury (abrasion) during use, but no injuries or illnesses have been reported, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Aesculap Implant Systems LLC is recalling the AESCULAP MINOP InVent 30 Trocar System, non-sterile (Item # FH620R). This medical device is intended for endoscopic procedures within the central nervous system, specifically for treating intra- and paraventricular pathological structures.
The recall was initiated because the device may have sharp edges on the distal end. These sharp edges may lead to the abrasion of the insulation when removing the electrode. The agency classifies this as a Class II recall.
A total of 21 units were distributed in the United States, with distribution also occurring in Canada. Healthcare providers and facilities should stop using the affected units and contact the manufacturer for further instructions.
The recalled product
- Product
- AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
- Affected units
- 21
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 (1)
- Item # FH620R
Distribution
Distribution scope not specified by the agency.
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