Z-1935-2026Class I

Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are...

Name: Z-1935-2026 Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are...
Creator: Cook Incorporated
Published: 2026-04-02
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2026-04-02 / Open, Classified

FDA source

Cook Incorporated began a recall of 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... on 2026-04-02. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1935-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-04-02
Posted: 2026-05-01
Recalling firm: Cook Incorporated
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 configurations (straight, PIG, and VCF).
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: On April 2, 2026, the firm began notifying affected consignees via letters titled "URGENT: MEDICAL DEVICE RECALL." Customers were instructed to quarantine affected products in inventory and to immediately cease further distribution and use of the affected products. They should return the affected products to Cook Medical with a copy of the completed Acknowledgement and Receipt form to receive a product credit.
Quantity in commerce: 271
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
Product codes and lots: UDI-DI 00827002473089 Lots 16858459 16869145 16857138 16763324 16750208 16752733 16821053 16713191

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1935-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1934-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01
Z-1935-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01
Z-1936-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01

Product code DQO

K162448Class IIWhite Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing CatheterCook Incorporated / cleared 2017-05-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)