Class I — Cook Incorporated
| Recalling firm | COOK, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| 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. |
| 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). |
| 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 |
| Initiated | 2026-04-02 |
| Classified | 2026-05-01 |
| Recall number | Z-1935-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Cook Incorporated (Z-1935-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98682/
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