Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues
Bard Peripheral Vascular Inc is recalling 239 units of EnCor Breast Biopsy Probes due to reports of leaks, suction issues, and failure to obtain tissue samples.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 high-risk medical device where the hazard (failure to obtain samples) poses a risk of harm to patient diagnosis, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 239 units of EnCor Breast Biopsy Probes, catalog number 12GV Upright (Vertical), REF ECP0112GV. The product is a single-use, prescription medical device indicated for acquiring tissue to diagnose breast abnormalities. The specific lot number is VTCW0467.
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 are packaged individually in sterile pouches, with five pouches per carton.
The affected units were distributed worldwide, including nationwide distribution in the United States and Puerto Rico. Foreign distribution included 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. There was no military distribution.
The recalled product
- Product
- EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 12GV Upright (Vertical) - REF ECP0112GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Biopsy Probe
- Affected units
- 239
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 (1)
- Lot number VTCW0467.
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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