Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral Dilation Balloon Cat...

FDA Device Recall #Z-1238-2016 — Class II — January 27, 2016

Recall Summary

Recall Number Z-1238-2016
Classification Class II — Moderate risk
Date Initiated January 27, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cook Inc.
Location Bloomington, IN
Product Type Devices
Quantity 20

Product Description

Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set is used for transluminal dilation of ureteral strictures or ureteral dilation prior to ureteroscopy and stone manipulation.

Reason for Recall

Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set because of a labeling mix-up. Cook Medical has received reports of packages labeled as Ultraxx" Nephrostomy Balloon Set actually containing the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set and vice versa.

Distribution Pattern

Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally to CHINA.

Lot / Code Information

Catalog # AUBS-6-4 GPN# G32840 Lot# 5083854 Exp: 06/01/2017

Other Recalls from Cook Inc.

Recall # Classification Product Date
Z-0388-2022 Class II Flexor Check-Flo Introducer Ansel Modification ... Nov 12, 2021
Z-0387-2022 Class II Flexor Check-Flo Introducer Ansel Modificatio... Nov 12, 2021
Z-0414-2022 Class II Skinny Needle with Chiba Tip. RPN 090010, 09001... Oct 13, 2021
Z-0222-2022 Class II Transseptal Needle, Trocar. RPN TSNC-18-71.0, T... Oct 8, 2021
Z-0223-2022 Class II Transseptal Needle with Catheter. RPN TSN-17-75... Oct 8, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.