Codman & Shurtleff, Inc.
Summary
- Total Recalls
- 59 (12 Class I)
- 510(k) Clearances
- 153
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2280-2019 | Class II | GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm). | May 16, 2019 |
| Z-1572-2014 | Class II | MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pum | November 10, 2015 |
| Z-1571-2014 | Class II | MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pum | November 10, 2015 |
| Z-1684-2015 | Class II | CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Const | March 5, 2015 |
| Z-0090-2015 | Class II | Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: | September 15, 2014 |
| Z-0091-2015 | Class II | Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-17 | September 15, 2014 |
| Z-0089-2015 | Class II | Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 8 | September 15, 2014 |
| Z-2189-2014 | Class II | Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8 | July 3, 2014 |
| Z-2185-2014 | Class II | Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Ce | July 3, 2014 |
| Z-2188-2014 | Class II | Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82-8804 The Codman Ce | July 3, 2014 |
| Z-2186-2014 | Class II | Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The | July 3, 2014 |
| Z-2187-2014 | Class II | Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-88 | July 3, 2014 |
| Z-2184-2014 | Class II | Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve i | July 3, 2014 |
| Z-2191-2014 | Class II | Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories | July 3, 2014 |
| Z-2190-2014 | Class II | Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82 | July 3, 2014 |
| Z-1468-2014 | Class II | CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Li | December 13, 2013 |
| Z-0789-2014 | Class I | TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial | October 11, 2013 |
| Z-0788-2014 | Class I | TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL via | October 11, 2013 |
| Z-2298-2013 | Class I | MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is i | August 13, 2013 |
| Z-2300-2013 | Class I | MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream programmable pu | August 13, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set | July 20, 2020 |
| K191237 | CERENOVUS Large Bore Catheter | November 8, 2019 |
| K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic | November 8, 2017 |
| K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag | October 16, 2017 |
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) | October 3, 2017 |
| K171862 | GALAXY G3 Mini Microcoil Delivery System | September 25, 2017 |
| K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microc | July 14, 2017 |
| K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up | July 3, 2017 |
| K162563 | YOGA Microcatheter | January 5, 2017 |
| K162437 | Codman EDS3 CSF External Drainage System | October 28, 2016 |
| K153347 | Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricu | August 19, 2016 |
| K152481 | DURAFORM Dural Graft Implant | October 30, 2015 |
| K150319 | MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIV | June 12, 2015 |
| K142429 | CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Del | December 24, 2014 |
| K140080 | ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB | April 24, 2014 |
| K140307 | ENVOY GUIDING CATHETER | April 21, 2014 |
| K133625 | AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, A | February 24, 2014 |
| K132281 | ReVive PV (Peripheral Vasculature) Thrombectomy Device | August 30, 2013 |
| K123560 | VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM | January 25, 2013 |
| K121776 | AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE | August 14, 2012 |