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Codman & Shurtleff Recalls
59 recalls on record · February 27, 2013 to August 21, 2019 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 21, 2019Medical DevicesFDA
Codman & Shurtleff Inc recalls GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).
Hazard: Incorrect coil length on the label
June 3, 2015Medical DevicesFDA
Codman & Shurtleff, Inc. recalls CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable
Hazard: Needle is leaking from hub/needle cannula connection
October 29, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for dr
Hazard: tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)
October 29, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated f
Hazard: tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)
October 29, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated fo
Hazard: tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)
August 20, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8
Hazard: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
August 20, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman
Hazard: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
August 20, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Ce
Hazard: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
August 20, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82-8804 The Codman Certas Programmable va
Hazard: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
August 20, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8803 The Codman Ce
Hazard: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
August 20, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Progra
Hazard: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
August 20, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable va
Hazard: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
August 20, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable dev
Hazard: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
May 21, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for th
Hazard: A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
May 21, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for th
Hazard: A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
April 23, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-88
Hazard: Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves.
February 5, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories P
Hazard: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
February 5, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-880
Hazard: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
February 5, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805
Hazard: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
February 5, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: Th
Hazard: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
February 5, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803
Hazard: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
February 5, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage:
Hazard: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
February 5, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Program
Hazard: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
January 29, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil a
Hazard: Incorrect instructions for use (IFU).
January 29, 2014Medical DevicesFDA
Codman & Shurtleff, Inc. recalls TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil
Hazard: Incorrect instructions for use (IFU).
October 9, 2013Medical DevicesFDA
Codman & Shurtleff, Inc. recalls MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream programmable pump is intended for t
Hazard: Drug flow rates exceeding programmed flow rates.
October 9, 2013Medical DevicesFDA
Codman & Shurtleff, Inc. recalls MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream programmable pump is intended for t
Hazard: Drug flow rates exceeding programmed flow rates.
October 9, 2013Medical DevicesFDA
Codman & Shurtleff, Inc. recalls MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the intr
Hazard: Drug flow rates exceeding programmed flow rates.
October 9, 2013Medical DevicesFDA
Codman & Shurtleff, Inc. recalls MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable pump is intended for the int
Hazard: Drug flow rates exceeding programmed flow rates.
October 9, 2013Medical DevicesFDA
Codman & Shurtleff, Inc. recalls MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable pump is intended for the intr
Hazard: Drug flow rates exceeding programmed flow rates.