Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, steril
FDA device recall Z-1935-2026 · posted 2026-05-01 · Open, Classified
Recall details
- Recalling firm
- Cook Incorporated
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DQO
- Quantity affected
- 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, Ur
- Date initiated
- 2026-04-02
- Date posted
- 2026-05-01
- Location
- Bloomington, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter (K162448) | Cook Incorporated | 2017-05-26 |