Agency classClass IOur severity:Critical FDA (Devices)·Z-1935-2026·Announced 2026-05-13

Aurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk

Cook Incorporated is recalling Aurous Centimeter Sizing Catheters due to risk of marker band cracking or breakage during angiographic procedures. Potential complications include device fragmentation, vessel injury, and in worst-case scenarios, life-threatening harm or death.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This is an FDA Class I recall, and the source text explicitly identifies a worst-case scenario involving "life-threatening harm or death." Per the rubric, FDA Class I recalls are never scored below 4, and explicit risk of death triggers a Critical (5) classification.

Plain-English summary

Cook Incorporated is recalling Aurous Centimeter Sizing Catheters (RPN N5.0-35-100-P-10S-PIG-CSC-20-01, GPN G47308) because the gold marker bands on these single-use, sterile catheters are at increased risk of cracking or breakage.

The recalled devices were distributed nationwide in the United States and internationally to Brunei, Brazil, Canada, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, and Uruguay. A total of 271 units were affected, including Lots 16858459, 16869145, 16857138, 16763324, 16750208, 16752733, 16821053, and 16713191.

If marker bands crack or break during an angiographic procedure, adverse events may include increased procedural time, device fragmentation or separation, and vessel injury. In worst-case scenarios, device fragmentation and separation may cause life-threatening harm or death.

Healthcare providers and patients who have received or used these catheters should contact Cook Incorporated immediately for guidance on the recalled product and potential replacement or corrective actions.

The recalled product

Product: 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…
Manufacturer: Cook Incorporated
Category: Medical Device — Cardiovascular / Angiographic Catheter
Hazard: device-fracture
device-separation
vessel-injury
life-threatening-harm
Affected units: 271

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Cook Incorporated

See all →

Critical
Cook Centimeter Sizing Catheter recall due to marker band cracking
FDA (Devices) · 2026-05-13
Severe
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Same hazard · device fracture