Reported Mar 20, 2024 · Ongoing
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter,…
Medos International Sarl
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medos International Sarl · Chemin Blanc 36 · Le Locle, N/A · N/A
Is this the product you have?
- CERENOVUS CEREBASE DA Guide Sheath
- Part Numbers
a) GS9080SDb) GS9090SDc) GS9095SDVascular guide-cathetersingle-use
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 10886704082316UPDATED 4/4/2024 UDI-DI 10886704082316, Lot numbers: 31121042, 31133636, 31140739, 31140751, 31146719, 31154809, 31160736, 31174927, 31178955, 31189206, 31194710, 31194733, 31208988, 31212653, 31212661 2 10886704082293GS9090SD: 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 3 10886704082323GS9095SD: UDI-DI 10886704082323, Lot Numbers: 31208992, 31212656 - Amount recalled
- 1343 units
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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