OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is designed to facilitate the...
FDA Device Recall #Z-0793-2017 — Class II — October 5, 2016
Recall Summary
| Recall Number | Z-0793-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 5, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Oscor, Inc. |
| Location | Palm Harbor, FL |
| Product Type | Devices |
| Quantity | 21 |
Product Description
OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Reason for Recall
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Distribution Pattern
Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM
Lot / Code Information
Lot #'s: C1-08337 Exp. November 7, 2016, OR-4658 Exp. April 20, 2018, C1-08337 Exp. November 7, 2016, and C1-08337 Exp. November 7, 2016
Other Recalls from Oscor, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1329-2021 | Class II | AngioDynamics SafeSheath ULTRALITE 10F, Model N... | Mar 10, 2021 |
| Z-0391-2019 | Class I | TB Series Bipolar Pacing Leads, French Size 4F... | Sep 26, 2018 |
| Z-2340-2017 | Class I | ATAR Reusable Extension Cable, sold under brand... | Mar 31, 2017 |
| Z-2733-2017 | Class I | ATAR Disposable Extension Cable, sold under bra... | Mar 31, 2017 |
| Z-0817-2017 | Class II | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F... | Oct 5, 2016 |
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.