Recall Z-1935-2026
Cook Incorporated · initiated April 2, 2026
Class I – dangerous or defective products that could cause serious health problems or death
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).
Codes / lots: UDI-DI 00827002473089 Lots 16858459 16869145 16857138 16763324 16750208 16752733 16821053 16713191
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-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1935-2026
- Initiated
- April 2, 2026
- Posted by FDA
- May 1, 2026
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Quantity
- 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
- Recalling firm
- Cook Incorporated, Bloomington, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1934-2026 Class I | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use…Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result… | 04/02/2026Open, Classified |
| Z-1936-2026 Class I | Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213…Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result… | 04/02/2026Open, Classified |