AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The ...
FDA Device Recall #Z-1401-2017 — Class II — January 31, 2017
Recall Summary
| Recall Number | Z-1401-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 31, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Boston Scientific Corporation |
| Location | Fremont, CA |
| Product Type | Devices |
| Quantity | 3402 units; 2626 in US; 786 units OUS |
Product Description
AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the Thrombectomy Set. It drives the pump, regulates fluid inflow and outflow, provides the operator with Ultra System set-up prompts, total infused saline volume, and Ultra System malfunction warnings.
Reason for Recall
Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot switch sticking during use resulting in an undesired continued operation of the device.
Distribution Pattern
US and Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Cyprus, Denmark, Dominican Rep., Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Indonesia, Iraq, Ireland, Israel, Italy, Jordan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Puerto Rico, Russian Fed. ,Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, United Arab Emir., Venezuela, Virgin Islands, W.Bank/Gaza Strip
Lot / Code Information
Serial number ranges:U2000 - U4530 U5001 - U5233; U6001 - U6197; U6300 - U6374 ; U6376 - U6432; U8001 - U8276; U8500 - U8719; U8800 - U8829; U8831 - U8869.
Other Recalls from Boston Scientific Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1551-2026 | Class II | EndoVive Safety PEG Kit; Outer Box Material Nu... | Feb 10, 2026 |
| Z-1160-2026 | Class I | AXIOS Stent and Electrocautery-Enhanced Deliver... | Dec 19, 2025 |
| Z-1162-2026 | Class I | *HOT AXIOS Stent and Electrocautery-Enhanced De... | Dec 19, 2025 |
| Z-1159-2026 | Class I | AXIOS Stent and Electrocautery-Enhanced Deliver... | Dec 19, 2025 |
| Z-1163-2026 | Class I | *HOT AXIOS Stent and Electrocautery-Enhanced De... | Dec 19, 2025 |
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.