Codman TRUFILL n-BCA Liquid Embolic System Recalled for Incorrect Instructions
Codman & Shurtleff, Inc. is recalling 3,860 units of the TRUFILL n-BCA Liquid Embolic System due to incorrect instructions for use.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must be at least 4 (Severe).
Plain-English summary
Codman & Shurtleff, Inc. is recalling 3,860 units of the TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System, Product Code 631-400. The recall is being conducted because the product contains incorrect instructions for use (IFU). The system is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.
The affected units were distributed nationwide in the United States, including Puerto Rico, as well as internationally to Costa Rica and Russia. All lot codes are included in this recall. The product consists of two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil, and one 1 g vial of Tantalum Powder.
The FDA has classified this recall as Class I. Users should contact Codman & Shurtleff, Inc. for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral…
- Manufacturer
- Codman & Shurtleff, Inc.
- Hazard
- Affected units
- 3,860
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot codes
Distribution
Part of a larger recall action
This product is one of 2 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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