POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture...
FDA Device Recall #Z-1770-2018 — Class II — February 8, 2018
Recall Summary
| Recall Number | Z-1770-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 8, 2018 |
| Status | Completed |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bard Peripheral Vascular Inc |
| Location | Tempe, AZ |
| Product Type | Devices |
| Quantity | 1411 units |
Product Description
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
Reason for Recall
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Distribution Pattern
Nationwide
Lot / Code Information
Lot Number Unique Device Identifier (UDI) REAN0061 (01)00801741110818(17)170628(10)REAN0061 REAP0772 (01)00801741110818(17)170728(10)REAP0772 REAT1524 (01)00801741110818(17)171128(10)REAT1524 REAV1479 (01)00801741110818(17)171228(10)REAV1479 REAV1938 (01)00801741110818(17)171028(10)REAV1938 REAW0937 (01)00801741110818(17)171031(10)REAW0937 REAW1186 (01)00801741110818(17)171031(10)REAW1186 REAW1666 (01)00801741110818(17)171031(10)REAW1666 REAY0528 (01)00801741110818(17)171031(10)REAY0528 REAY0795 (01)00801741110818(17)171031(10)REAY0795 REAZ1529 (01)00801741110818(17)171231(10)REAZ1529 REBN0024 (01)00801741110818(17)171231(10)REBN0024 REBN1581 (01)00801741110818(17)180131(10)REBN1581 REBQ0210 (01)00801741110818(17)180131(10)REBQ0210 REBS1277 (01)00801741110818(17)181031(10)REBS1277 REBR1125 (01)00801741110818(17)181031(10)REBR1125 REBS1395 (01)00801741110818(17)181031(10)REBS1395 REBS2412 (01)00801741110818(17)181130(10)REBS2412 REBT1785 (01)00801741110818(17)181231(10)REBT1785 REBT2349 (01)00801741110818(17)181231(10)REBT2349 REBU0563 (01)00801741110818(17)181231(10)REBU0563 REBV0760 (01)00801741110818(17)190228(10)REBV0760 REBW1037 (01)00801741110818(17)190331(10)REBW1037
Other Recalls from Bard Peripheral Vascular Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1367-2026 | Class II | Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown... | Dec 12, 2025 |
| Z-0887-2026 | Class II | Safe-T-Centesis 6 Fr Catheter Drainage Tray, RE... | Nov 6, 2025 |
| Z-2638-2025 | Class II | Venclose digiRF Generators, Model VCRFG1, with ... | Aug 21, 2025 |
| Z-1244-2025 | Class I | Rotarex Atherectomy System and Instructions for... | Feb 5, 2025 |
| Z-0467-2025 | Class II | Bard Marquee Disposable Core Biopsy Instrument ... | Sep 30, 2024 |
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.