fda_recall · device_recall · critical

Cook Incorporated — Class I recall: Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Cath…

Event date
2026-05-13 00:00:00Z
Observed
2026-07-09 22:52:42Z
Source ID
Z-1934-2026
Payload hash
0d3935360a118f5a95ed4bd5

Summary

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatenin… Status: Ongoing.

Informational only. Not legal, financial, or medical advice.