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n.a.
Karl Storz GmbH & Co. KG · Model 27618 · UDI-DI 04048551086025
KNY
Prescription
10
510(k) clearances
392
Adverse events (2 deaths)
3
Recalls
39
Facilities
Description
Insertion Mandrin
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-11 | Olympus Corporation of the Americas | Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients |
| 2023-05-19 | Olympus Corporation of the Americas | Dilator tips may break in the package and in patients during surgical procedures. |
| 2011-04-15 | Gyrus Acmi, Incorporated | Gyrus ACMI, Inc. wants to bring a recall issue to their customers attention concerning one lot of their 25BX-PTFE Coated 3 cm Flexible Tip Guidewire. As a result of a manufacturin |
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