Recall Z-1284-2024— Medos International Sarl

Name: FDA recall Z-1284-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-02

Class I · Ongoing

Class I FDA medical device recall by Medos International Sarl, initiated 2024-02-02. It names one FDA 510(k) clearance: K192804. Product: CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use. Reason: 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..

Recalling firm: Medos International Sarl
Classification: Class I
Status: Ongoing
Initiated: 2024-02-02
Firm location: Le Locle, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K192804 — CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cmMedos International SARL·cleared 2020-02-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.