Codman & Shurtleff, Inc.
United StatesFDA applicant, unverified
- Devices
- 153
- FDA recalls
- 78
At a glance
Market reach
- United States
- FDA recalls
What Codman & Shurtleff, Inc. makes
Codman & Shurtleff, Inc. manufactures medical devices for neurosurgery, vascular interventions, and orthopedics, including external ventricular drainage catheters, bipolar forceps, detachable and pushable embolization coils, pituitary retractors, and shunt systems for cerebrospinal fluid management. Their portfolio also includes orthopedic implants like the Charnley femoral component, microcoil delivery systems, and surgical tools such as curettes and soft-wire kits for spinal applications.
The company’s devices are regulated under FDA’s Class I and Class II classifications, with most products cleared via the 510(k) pathway. These products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Search and filter all 153 devicesShowing 1-50 of 153
FDA recalls
FDA recall records list 78 recalls initiated by Codman & Shurtleff, Inc., the earliest on 2004-03-11 and the most recent on 2019-05-16. By recorded status: 78 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, electrical or power, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 16 May 2019 Z-2280-2019 Class II Terminated Incorrect coil length on the label
2015
- 10 Nov 2015 Z-1571-2014 Class II Terminated A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
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- 10 Nov 2015 Z-1572-2014 Class II Terminated A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
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- 5 Mar 2015 Z-1684-2015 Class II Terminated Needle is leaking from hub/needle cannula connection
- 10 Nov 2015 Z-1571-2014 Class II Terminated A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
2014
- 15 Sep 2014 Z-0089-2015 Class II Terminated 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)
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- 15 Sep 2014 Z-0090-2015 Class II Terminated 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)
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- 15 Sep 2014 Z-0091-2015 Class II Terminated 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)
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- 3 Jul 2014 Z-2184-2014 Class II Terminated To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
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- 3 Jul 2014 Z-2185-2014 Class II Terminated To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
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- 3 Jul 2014 Z-2186-2014 Class II Terminated To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
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- 15 Sep 2014 Z-0089-2015 Class II Terminated 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)
Show the 25 most recent of 78 recalls
2014
- 3 Jul 2014 Z-2187-2014 Class II Terminated To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
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- 3 Jul 2014 Z-2188-2014 Class II Terminated To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
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- 3 Jul 2014 Z-2189-2014 Class II Terminated To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
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- 3 Jul 2014 Z-2190-2014 Class II Terminated To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
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- 3 Jul 2014 Z-2191-2014 Class II Terminated To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
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- 3 Jul 2014 Z-2187-2014 Class II Terminated To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
2013
- 13 Dec 2013 Z-1468-2014 Class II Terminated 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.
- 11 Oct 2013 Z-0788-2014 Class I Terminated Incorrect instructions for use (IFU).
- 11 Oct 2013 Z-0789-2014 Class I Terminated Incorrect instructions for use (IFU).
- 13 Aug 2013 Z-2293-2013 Class I Terminated Drug flow rates exceeding programmed flow rates.
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- 13 Aug 2013 Z-2294-2013 Class I Terminated Drug flow rates exceeding programmed flow rates.
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- 13 Aug 2013 Z-2295-2013 Class I Terminated Drug flow rates exceeding programmed flow rates.
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- 13 Aug 2013 Z-2296-2013 Class I Terminated Drug flow rates exceeding programmed flow rates.
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- 13 Aug 2013 Z-2297-2013 Class I Terminated Drug flow rates exceeding programmed flow rates.
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- 13 Aug 2013 Z-2298-2013 Class I Terminated Drug flow rates exceeding programmed flow rates.
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- 13 Aug 2013 Z-2299-2013 Class I Terminated Drug flow rates exceeding programmed flow rates.
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Frequently asked questions
How many devices does Codman & Shurtleff, Inc. have in the registry?
The registry currently lists 153 devices for Codman & Shurtleff, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Codman & Shurtleff, Inc.'s devices?
Among its 50 most recently registered devices, Codman & Shurtleff, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Codman & Shurtleff, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Codman & Shurtleff, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Codman & Shurtleff, Inc.?
FDA recall records list 78 recalls initiated by Codman & Shurtleff, Inc., the most recent initiated on 2019-05-16. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Codman & Shurtleff, Inc. in the registry?
The most recently registered devices listed for Codman & Shurtleff, Inc. include CODMAN BACTISEAL EVD CATHETER SET, CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II), ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM and CHARNLEY FEMORAL COMPONENT.