HIGH

Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 ...

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.

Quick Facts at a Glance

Recall Date
April 2, 2026
Hazard Level
HIGH
Brand
Cook
Geographic Scope
1 states

Hazard Information

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 You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Incorporated or your healthcare provider for instructions. Notification method: Letter

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Full Description

Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 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).. Reason: 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.. Classification: Class I. Quantity: 4,245. 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

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Brand
Cook
Model Numbers
G31213 UDI-DI 00827002312135 Lot 16805456 G31214 UDI-DI 00827002312142 Lots 16886459 16874181 16855513 16867505 16815763 16796665 16802282 16766437 16734169 16695772 G31216 UDI-DI 00827002312166 Lots 16886460 16891299 16912494 16831676 16836358 16836359 16836360 16864534 16864652 16881655 16882508 16912493 16872559 16878260 16824312 16831675 16874182 16855514 16868889 16859732 16858079 16878261 16806270 16804619 16805454 16804399 16815762 16803920 16803921 16802096 16802097 16814369 16814370 16806333 16804620 16831528 16822289 16822290 16782945 16782946 16795733 16796300 16779437 16795734 16800424 16802632 16824313 16764526 16763024 16800730 16802633 16802133 16800731 16821105 16824314 16711110 16717839 16730326 16720153 16736740 16739291 16693653 16690051 16673569 16680240 16704378 G31220 UDI-DI 00827002312203 Lots 16881657 16872241 16827163 16852999 16805455 16804400 16802132 16779438 16730325 16739292 16700199 16690050 16661312 16674400 G31221 UDI-DI 00827002312210 Lots 16839296 16879977 16814371 16821104
Affected States
ALL
Report Date
May 13, 2026
Recall Status
ACTIVE

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