FDAApril 2, 2026device

Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of cathet...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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-threatening harm or death.

What to do

FDA enforcement status: Ongoing

Brands named

cook

UPCs

00827002119161

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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