FDA Device recall Z-1935-2026
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 go…
- FDA Device
- Class I
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class I 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 go… by Cook, citing 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 fragmentati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1935-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-04-02 |
| Published | 2026-05-13 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Cook |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI-DI 00827002473089 Lots 16858459 16869145 16857138 16763324 16750208 16752733 16821053 16713191 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1935-2026%22
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