Codman Certas Programmable Valves Recalled for Potential Malfunction
Codman & Shurtleff, Inc. is recalling 431 Codman Certas Programmable Valves because they may not operate properly. These implantable devices are used to manage hydrocephalus.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant injury or structural defects in medical devices.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 431 units of the Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories (Product Code: 82-8803). The recall is being conducted because the valves may not operate properly. The device is an implantable medical device used to provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus.
The affected units were distributed worldwide, including in the United States, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and the UK. Specific lot codes for the affected units include CLPCM9, CMBBB2, CMBBB3, CMDBHD, CMDCN7, CMDDJT, CMFBNK, CMFBNL, CMNBZG, CNDCP3, CNGBK5, CNHCZP, CNJB1F, CNJC4R, CNJCMP, CNKB0Y, CNLCL0, CNMCYY, CNMDNJ, CNNDH0, CNPBRK, CNPCLW, CPBBGR, CPCCBC, CPCCML, and CPDCC2.
Patients who have received these devices should contact their healthcare provider for further instructions. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospi
- Manufacturer
- Codman & Shurtleff, Inc.
- Affected units
- 431
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Codman & Shurtleff, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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