FDA recall Z-1284-2024

Product

CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use

Reason for recall

Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-02-02

Report date

2024-03-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Le Locle, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1284-2024