ENCOR recallZ-1432-2020 · Bard Peripheral Vascular Inc · initiated Jan 3, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bard Peripheral Vascular Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component change control
What the company is doing
The recalling firm issued letters dated 1/3/2020 to each of the U.S. consignees via FedEx with proof of delivery notification. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-321-4254 Option #5.
Recall details
- Recall number
- Z-1432-2020
- Status
- Terminated
- Initiated by the company
- Jan 3, 2020
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 1,585 units
- Product code
- KNW
- FDA submissions
- K040842, K051158
- Distribution
- 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.
Product description
Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Code information (models, lots, serial numbers)
Lot numbers VTCT0272 and VTCV0384. UDI numbers (01)00801741086328(17)200601(10)VTCT0272 and (01)00801741086328(17)200801(10)VTCV0384.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ENCOR® ECPMR017GSenorx, Inc. · INSTRUMENT, BIOPSY1 recall0 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K040842, K051158 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ENCOR® ECP017GSenorx, Inc. · INSTRUMENT, BIOPSY1 recall4,186 reports
- ENCOR® ECP017GVSenorx, Inc. · INSTRUMENT, BIOPSY243 reports
- ENCOR® ECP0112GSenorx, Inc. · INSTRUMENT, BIOPSY36 reports
- ENCOR® ECP0112GVSenorx, Inc. · INSTRUMENT, BIOPSY2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 84929).
- Z-1431-2020 · TerminatedBard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
- Z-1433-2020 · TerminatedBard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
- Z-1434-2020 · TerminatedBard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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