FDAClass I · Medical device · Recalled May 13, 2026

Aurous Centimeter Sizing Catheter RPN N5 recall — Cook Incorporated

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.

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1935-2026
Brand: Cook Incorporated
Classification: Class I
Units affected: 271
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).

Affected products

Aurous Centimeter Sizing Catheter RPN N5

Companies & origin

Recalling firm location: Bloomington, IN, United States
Firm address: 750 N Daniels Way, 47404-9120

Identifying details (verbatim from the notice)

Product codes / lots: UDI-DI 00827002473089 Lots 16858459 16869145 16857138 16763324 16750208 16752733 16821053 16713191
Distribution: US distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, Uruguay
Firm notified the public via: Letter
FDA event ID: 98682
Recall initiated: April 2, 2026
FDA classified: May 1, 2026
FDA report date: May 13, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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