CLASS I ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report
Aurous Centimeter Sizing Catheter RPN recalled by Cook Incorporated
Cook is recalling Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-Pig-csc-20-01 GPN G47308 Sizing, distributed nationwide in the US. The recall was initiated on 2 Apr 2026 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1935-2026
- FDA event ID
- 98682
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 2 Apr 2026
- FDA classified
- 1 May 2026
- Reported
- 13 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 2 Apr 2026 | Recall initiated by company | |
| 1 May 2026 | Classified by FDA | +29 days |
| 13 May 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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).
Where it was distributed
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
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI 00827002473089 Lots 16858459 16869145 16857138 16763324 16750208 16752733 16821053 16713191
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 98682This product is part of a recall event; the main page for the event is Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-Pig-csc recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-Pig-csc recalled | Cook | Device Malfunction | Nationwide | |
| CLASS I | Beacon Tip Centimeter Sizing Catheter RPN/GPN recalled | Cook | Device Malfunction | Nationwide |
More recalls from Cook
All 350| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Williams Cystoscopic Injection Needles, used recalled by Cook | Cook | Device Malfunction | 5 states |
| Device | CLASS I | Beacon Tip Centimeter Sizing Catheter RPN/GPN recalled | Cook | Device Malfunction | Nationwide |
| Device | CLASS I | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-Pig-csc recalled | Cook | Device Malfunction | Nationwide |
| Device | CLASS II | Medical Cook Staged Extubation Set: Reference recalled | Cook | Other | IN |
| Device | CLASS II | Medical Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference recalled | Cook | Other | IN |
Other Heart & Vascular Devices recalls
All 6,268| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Fathom/027/Straight/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/155 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/J/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |