NeuroBlate System SideFire Select 2.2 mm Directional recall
NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01…
Why was NeuroBlate System SideFire Select 2.2 mm Directional recalled?
Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient's brain.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All unexpired lots of these models are being removed from the market.
- Product
- NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01…
- Recalling firm
- Monteris Medical Corp
- Quantity
- 121
- Distribution
- Nationwide Distribution in the states of KS, MO, NC, OH, and VA.
- Recall date
- May 25, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)