CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-cathe
Summary
The FDA issued a Class I for CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD by Medos International Sarl. 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 pr.
Details
Source
Device Recall
External ID
Z-1284-2024
Action Date
2024-03-20
Status
Ongoing
Category
device
Product Description
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
Lot/Code Info: a) GS9080SD: UPDATED 4/4/2024 UDI-DI 10886704082316, Lot numbers: 31121042, 31133636, 31140739, 31140751, 31146719, 31154809, 31160736, 31174927, 31178955, 31189206, 31194710, 31194733, 31208988, 31212653, 31212661; b) GS9090SD: UPDATED 4/4/2024 UDI-DI 10886704082293, Lot numbers: 31094249, 31103843, 31108260, 31116484, 31116485, 31121039, 31121040, 31121043, 31121044, 31133637, 31133638, 31140740, 31140952, 31146720, 31150968, 31150969, 31154810, 31154811, 31160737, 31160738, 31168610, 31168611, 31174928, 31174930, 31178956, 31178957, 31178958, 31189207, 31189208, 31194711, 31194712, 31194734, 31194735, 31204436, 31208989, 31208990, 31208991, 31212654, 31212655, 31212663, 31225738; c) GS9095SD: UDI-DI 10886704082323, Lot Numbers: 31208992, 31212656
Quantity Affected: 1343 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-02
Company
Le Locle, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medos International Sarl has 22 FDA actions in our database, including 1 recall and 21 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medos International Sarl) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medos International Sarl have FDA actions?
Medos International Sarl has 22 FDA actions in our database, including 1 recall and 21 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1284-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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