Vascular guide catheter recalled due to distal end fracture risk
Medos is recalling CERENOVUS CEREBASE DA Guide Sheaths due to reports of fractures at the distal end. Fractures may delay surgical procedures or cause vascular injury.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I designation mandates a minimum severity score of 4. This vascular surgical device exhibits a reported structural defect with potential for serious medical consequences including vascular injury and embolism, despite no deaths or injuries reported to date.
Plain-English summary
Medos International Sarl is recalling CERENOVUS CEREBASE DA Guide Sheaths, single-use vascular guide-catheters, due to reports of fractures at the distal end. The recall affects 1,343 units distributed worldwide, with specific lot numbers identified for affected part numbers GS9080SD, GS9090SD, and GS9095SD.
Fractures in these devices may result in surgical procedural delay, vascular injury, or in extreme rare cases, embolism. The source documentation does not specify the number of fracture incidents reported or any confirmed patient injuries resulting from the defect.
Healthcare facilities and providers with affected lot numbers should cease use of these devices and contact Medos International Sarl for return and replacement instructions. Patients with questions about devices they may have received should consult their healthcare provider.
The recalled product
- Product
- CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
- Manufacturer
- Medos International Sarl
- Affected units
- 1,343
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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