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CEREGLIDE
Cerenovus, Inc. · Model CS71125U · UDI-DI 10886704088097
1
510(k) clearances
1,858
Adverse events (51 deaths)
7
Recalls
75
Facilities
Description
CEREGLIDE 71 INNERGLIDE 7 125 cm 165 cm 0.071 in (1.80 mm) 0.030 in (0.76 mm) 0.082 in (2.08 mm) 0.042 in (1.07 mm) 0.0825 in (2.10 mm) 0.059 in (1.50 mm) 0.085 in (2.16 mm) Minimum Guide Diameter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-16 | Scientia Vascular, Inc. | Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier. |
| 2024-08-30 | Stryker Neurovascular | Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configuration |
| 2024-04-23 | Stryker Neurovascular | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so t |
| 2024-03-08 | ROUTE 92 MEDICAL INC | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters. |
| 2024-03-08 | ROUTE 92 MEDICAL INC | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters |
| 2024-02-02 | Medos International Sarl | 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 injur |
| 2023-12-06 | Stryker, Inc. | The microcatheter IFU contains an intended use that has not been evaluated by the FDA. |
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