FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
- Recall number
- Z-2209-2019
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
- Status
- Terminated
- Initiated
- 2019-05-02
- Posted
- not on file
- Terminated
- 2022-03-03
- Reason
- There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
- Root cause
- Component change control
- Action
- The recalling firm issued letters dated 4/19/2019 via FedEx on 4/19/2019 with proof of delivery to the U.S. customers. The letters sent to foreign countries vary depending on the format required for the country.
- Quantity
- 36,640 units
- Distribution
- Worldwide distribution - US Nationwide distribution, including Puerto Rico. There was government and foreign distribution and no military distribution. Foreign distribution was made to Canada, Algeria, Australia, Austria, Belgium, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Gibraltar, Greece, Guadeloupe, Hungary, Iceland, India, Ireland, Italy, Japan, Korea, Kuwait, Luxembourg, Malaysia, Martinique, Monaco, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.
- Lot, serial or model codes
- Lot numbers VTCT0306, VTCT0307, VTCU0358 VTCU0359, VTCU0360, VTCU0361, VTCV0369, VTCW0454, VTCW0455, VTCW0456, VTCW0479, VTCX0482, VTCX0483, VTCX0484, VTCY0536, VTCY0544, VTCY0545, VTCY0546, VTCY0547, VTCZ0637, VTCZ0638, VTCZ0639, VTCZ0641, VTCZ0647, VTDN0035, and VTDN0036.
- 510(k) numbers
- ["K040842","K051158"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 2020394
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28