NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, S
FDA device recall Z-1614-2016 · posted 2016-05-16 · Terminated
Recall details
- Recalling firm
- Monteris Medical Corp
- Reason for recall
- 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.
- Action taken
- Monteris Medical Corporation field personnel visited each consignee starting March 25, 2016 and April 1, 2016. The devices were physically removed from each site. Customers from whom the devices were removed will either receive a credit or receive replacements of other models of laser delivery probes.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 121
- Distribution
- Nationwide Distribution in the states of KS, MO, NC, OH, and VA.
- Date initiated
- 2016-03-25
- Date posted
- 2016-05-16
- Date terminated
- 2017-03-10
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NeuroBlate System (K143457) | Monteris Medical, Inc. | 2015-02-19 |