Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest ...
FDA Device Recall #Z-1121-2014 — Class III — February 6, 2014
Recall Summary
| Recall Number | Z-1121-2014 |
| Classification | Class III — Low risk |
| Date Initiated | February 6, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Vascular |
| Location | Danvers, MA |
| Product Type | Devices |
| Quantity | 191 devices |
Product Description
Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.
Reason for Recall
Incorrect master label.
Distribution Pattern
Nationwide Distribution including TX, ME, IA, PA, OR, and NH.
Lot / Code Information
Lot Number: 50755851
Other Recalls from Medtronic Vascular
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1860-2021 | Class I | Angiographic Guidewire Component: Model Number:... | May 4, 2021 |
| Z-1245-2021 | Class II | Medtronic 6F Launcher Guide Catheter 100 cmJL 3... | Jan 15, 2021 |
| Z-1247-2021 | Class II | Medtronic 6F Launcher Guide Catheter 100cm EBU ... | Jan 15, 2021 |
| Z-1246-2021 | Class II | Medtronic 6F Launcher Guide Catheter 100 cm JR... | Jan 15, 2021 |
| Z-1248-2021 | Class II | Medtronic 6F Launcher Guide Catheter 100 cm EBU... | Jan 15, 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.