Detachable brain aneurysm coils recalled because they may fail to detach
Cerenovus is recalling 12,004 CEREPAK Detachable Coil System units because the coils may fail to detach, which could result in hemorrhagic and ischemic stroke. The FDA classified it Class I.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.
Plain-English summary
The CEREPAK Detachable Coil System from Cerenovus is being recalled across the UNIFORM range, including REFs FCX100202 (2 mm x 2.5 cm), FCX100253, FCX100305, FCX100356, FCX100407 and FCX100412.
The detachable coil system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.
The recall covers 12,004 units. All devices and lots manufactured prior to and including August 2025 are affected. The product was distributed nationwide in the United States including Colorado, Georgia, Maryland, Utah, Oklahoma, Wisconsin, Massachusetts, Tennessee, South Carolina, Texas, California, West Virginia, Louisiana, Illinois, New York, Iowa, Arizona, Alabama, Connecticut, Washington and Ohio. The FDA has classified the recall as Class I, its most serious category.
Facilities should quarantine affected stock immediately and follow Cerenovus' instructions.
The recalled product
- Product
- CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM…
- Manufacturer
- Cerenovus Inc
- Affected units
- 12,004
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 (20)
- FCX100253/10886704083979
- FCX100305/10886704083962
- FCX100356/10886704083993
- FCX100407/10886704084013
- FCX100412/10886704084006
- FCX100509/10886704084037
- FCX100517/10886704084020
- FCX100611/10886704084044
- FCX100626/10886704084051
- FCX100713/10886704084068
- FCX100730/10886704084075
- FCX100816/10886704084082
- FCX100829/10886704084099
- FCX140225/10886704084167
- FCX140303/10886704084174
- FCX140304/10886704084181
- FCX140306/10886704084198
- FCX140406/10886704084211
- FCX140408/10886704084228
- FCX140445/10886704084204
Distribution
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