Urgent Field Safety Notice For S.-ella Stent Danis (danis Stent) By Ella-cs, S.r.o.

Recall Summary ELLA-CS, s.r.o. has issued a Class I recall for S.-ELLA Stent Danis (Danis Stent) devices distributed in Germany and the EU. The specific reason for the recall is not clearly detailed in the available information. This is the highest class of recall, indicating a serious issue with the product.

Recalling firm

Urgent Field Safety Notice for S.-ELLA Stent Danis (Danis Stent) by ELLA-CS, s.r.o. , Download_VeroeffentlichtAm_EN 2026

Product

s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for S

Reason

assessment Field corrective actions Urgent Field Safety Notice for S

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-05-07

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/ebffe58f-5169-4d12-838f-7009f517278c