Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sh...
FDA Device Recall #Z-1276-2015 — Class I — February 23, 2015
Recall Summary
| Recall Number | Z-1276-2015 |
| Classification | Class I — Serious risk |
| Date Initiated | February 23, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Inc. Cardiac Rhythm Disease Management |
| Location | Saint Paul, MN |
| Product Type | Devices |
| Quantity | 151 (4 US, 147 OUS) |
Product Description
Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.
Reason for Recall
Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.
Distribution Pattern
Worldwide Distribution: US (nationwide) in states of: NC and IA; and countries of: AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, NETHERLANDS, POLAND, SPAIN, and UNITED KINGDOM.
Lot / Code Information
Lot Number: 54790, 54860, 54876, 54877, 54878 ,72417, 72419.
Other Recalls from Medtronic Inc. Cardiac Rhythm Disease...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0022-2016 | Class II | Medtronic Medical Device Identification Card fo... | Sep 15, 2015 |
| Z-2777-2015 | Class II | Medtronic CryoConsole, models 106A3, 106E2, and... | Sep 1, 2015 |
| Z-1365-2015 | Class II | Covidien Trellis 6 and Trellis 8 Peripheral Inf... | Mar 23, 2015 |
| Z-1356-2015 | Class II | Medtronic Dual Chamber Temporary External Pacem... | Mar 17, 2015 |
| Z-1661-2014 | Class II | Medtronic Temporary Pacemaker, Model 5348. Sing... | Apr 29, 2014 |
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.