Aurous Centimeter Sizing Catheter RPN N5 — Class I medical device recall Z-1935-2026
Ongoing recall by Cook Incorporated, reported 2026-05-13, distributed nationwide. Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result includ
| Recall number | Z-1935-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Incorporated, Bloomington, IN, United States |
| Recall initiated | 2026-04-02 |
| Classified | 2026-05-01 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CN, CO, CR, HK, IL, IN, JP, KR, NZ, SG, SV, TW, UY |
| Quantity | 271 |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00827002473089 |
| Lot numbers | 16713191, 16750208, 16752733, 16763324, 16821053, 16857138, 16858459, 16869145 |
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).
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1935-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.