Codman TRUFILL n-BCA Liquid Embolic System Recalled for Incorrect Instructions
Codman & Shurtleff, Inc. is recalling 7,983 units of the TRUFILL n-BCA Liquid Embolic System due to incorrect instructions for use.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which is defined as unlikely to cause adverse health consequences. The hazard is limited to documentation issues (incorrect instructions for use) with no reported injuries or illnesses.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 7,983 units of the TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System, Product Code 631-500. 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 worldwide, including nationwide in the United States (including Puerto Rico), as well as to Costa Rica and Russia. The recall covers all lot codes. No specific illnesses or injuries are reported in the source text.
Healthcare providers and facilities should stop using the affected TRUFILL n-BCA Liquid Embolic System units and contact Codman & Shurtleff, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arterioveno
- Manufacturer
- Codman & Shurtleff, Inc.
- Hazard
- Affected units
- 7,983
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Codman & Shurtleff, Inc.
See all →- ModerateCodman Galaxy G3 Mini Microcoil Delivery System Recalled for Labeling Error
FDA (Devices) · 2019-08-21
- HighCodman 3000 Series Refill Set Recalled for Leaking Needles
FDA (Devices) · 2015-06-03
- HighCodman EDS 3 Drainage System Recalled for Tubing Leak Risk
FDA (Devices) · 2014-10-29
- SevereCodman EDS 3 Drainage System Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29
- SevereCodman Lumbar Drainage Catheter Kit Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02