Cook Centimeter Sizing Catheter
Cook recalls Centimeter Sizing Catheter (RPN N5.0-35-100-P-10S-PIG-CSC-20) over marker band cracking risk.
If you have the affected Centimeter Sizing Catheter (RPN N5.0-35-100-P-10S-PIG-CSC-20, GPN G11916), stop using it immediately and contact Cook Incorporated for instructions on returning the device and obtaining a replacement.
Why it was recalled
Cook Incorporated is recalling its Centimeter Sizing Catheter (RPN N5.0-35-100-P-10S-PIG-CSC-20, GPN G11916) because the marker bands may be at an increased risk of cracking or breakage. This can lead to device fragmentation or separation, potentially causing vessel injury or life-threatening harm.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Recall # | UDI-DI |
|---|---|---|
| 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). | Z-1935-2026 | 00827002473089, 16858459, 16869145, 16857138, 16763324, 16750208, 16752733, 16821053, 16713191 |
| 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). | Z-1936-2026 | 00827002312135, 16805456, 00827002312142, 16886459, 16874181, 16855513, 16867505, 16815763, 16796665, 16802282, 16766437, 16734169, 16695772, 00827002312166, 16886460, 16891299, 16912494, 16831676, 16836358, 16836359 |
| 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 catheter material for different angiographic procedures should be based on the physician s experience. | Z-1934-2026 | 00827002119161, 16905390, 16888263, 16905391, 16909577, 16918137, 16924645, 16924646, 16928311, 16928312, 16928313, 16947353, 16899656, 16899655, 16894976, 16879299, 16890985, 16903201, 16885859, 16890986 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Cook Incorporated
Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification