Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints of leaks, suction issues, and failure to obtain tissue samples.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with functional failures (leaks, suction issues, failure to obtain samples) that pose a risk of harm (diagnostic failure) but does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 29,918 units of EnCor Breast Biopsy Probes, catalog number 10GV Upright (Vertical), REF ECP0110GV. These single-use, prescription medical devices are indicated for acquiring tissue to diagnose breast abnormalities. The affected lots are VTCT0273, VTCT0308, VTCT0309, VTCU0351, VTCU0352, VTCW0451, VTCW0452, VTCW0453, VTCX0485, VTCX0486, VTCX0487, VTCY0548, VTCY0549, VTCY0550, VTCZ0642, VTCZ0643, VTCZ0644, and VTCZ0645.
The recall was initiated due to an increase in complaints regarding leaks, suction issues, and the failure to obtain samples while using the product. The devices were distributed worldwide, including nationwide in the United States and Puerto Rico, as well as to numerous foreign countries.
Healthcare providers and facilities should stop using the affected devices and contact Bard Peripheral Vascular Inc for instructions on return or replacement. Patients who have had procedures using these devices should contact their healthcare provider if they have concerns about the results of their biopsy.
The recalled product
- Product
- EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 10GV Upright (Vertical) - REF ECP0110GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 29,918
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- Lot numbers VTCT0273
- VTCT0308
- VTCT0309
- VTCU0351
- VTCU0352
- VTCW0451
- VTCW0452
- VTCW0453
- VTCX0485
- VTCX0486
- VTCX0487
- VTCY0548
- VTCY0549
- VTCY0550
- VTCZ0642
- VTCZ0643
- VTCZ0644
- and VTCZ0645.
Distribution
Part of a larger recall action
This product is one of 6 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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