Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in ste...

FDA Device Recall #Z-1433-2020 — Class II — January 3, 2020

Recall Summary

Recall Number Z-1433-2020
Classification Class II — Moderate risk
Date Initiated January 3, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bard Peripheral Vascular Inc
Location Tempe, AZ
Product Type Devices
Quantity 2,050 units

Product Description

Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.

Reason for Recall

Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.

Distribution Pattern

Distribution was made to AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, SC, TX, VA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Canada, Australia, Austria, Belgium, China, Czech Republic, Germany, France, Georgia, Greece, Hong Kong, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

Lot / Code Information

Lot number VTCW0468; UDI number (01)00801741086304(17)200901(10)VTCW0468.

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.