CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
Reported: March 20, 2024 Initiated: February 2, 2024 #Z-1284-2024
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.
Details
- Recalling Firm
- Medos International Sarl
- Units Affected
- 1343 units
- Distribution
- Worldwide distribution.
- Location
- Le Locle, N/A
Frequently Asked Questions
What product was recalled? ▼
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use. Recalled by Medos International Sarl. Units affected: 1343 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 20, 2024. Severity: Critical. Recall number: Z-1284-2024.
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