Trocar with oversized shaft obscures surgical view in brain operations
Aesculap trocars manufactured with shafts too long obstruct the visual field when used with neuroendoscopes in brain surgery. Affected units distributed in nine states should not be used.
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: FDA Class II surgical device with a manufacturing defect that impairs surgical visualization during critical neurosurgical procedures. No illnesses or injuries have been reported, but the defect creates significant risk of harm during delicate brain surgery where impaired visibility could lead to serious complications.
Plain-English summary
Aesculap Implant Systems LLC is recalling certain trocars (surgical instruments used in brain surgery) due to a manufacturing defect. The recalled instruments have shafts manufactured to exceed their specified length, failing to meet manufacturing specifications.
When used with a 30-degree neuroendoscope during intraventricular brain procedures, the oversized shaft partially obstructs the surgeon's visual field. This obstruction could compromise the surgeon's ability to visualize the surgical area during the procedure.
The affected products were distributed nationwide to medical facilities in Florida, Idaho, Illinois, Maryland, North Carolina, New York, Oregon, Rhode Island, and Texas. A total of 25 units are subject to this recall, with specific lot and serial numbers identified by the manufacturer.
Healthcare facilities that received these trocars should immediately cease use of the affected units and contact Aesculap Implant Systems LLC for replacement or instructions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
- Manufacturer
- Aesculap Implant Systems LLC
- Affected units
- 25
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 (20)
- UDI-DI: 04038653065547 Lot Numbers: 52750146 52753381
- 52756472
- 52768317
- 52805655
- 52812596
- 52816570
- 52823878
- 52830872. Serial Numbers: 4281
- 4282
- 4284
- 4288
- 4289
- 4291
- 4308
- 4309
- 4310
- 4312
- 4313
- 4336
- 4340
Distribution
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