Bard Biopsy EnCor Probe Recall for Performance Failures
Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to performance failures including leaks and suction issues.
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 medical device with performance failures (leaks, suction issues) that pose a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 1,585 units of Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G. The recall covers lot numbers VTCT0272 and VTCV0384. These products were distributed to 31 U.S. states and 27 foreign countries.
The recall was initiated because these specific lots were inadvertently omitted from the scope of a previous recall. The original recall was conducted due to an increase in probe failures, specifically leaks, suction issues, and the failure to obtain samples.
Healthcare facilities and distributors should stop using the affected products and contact Bard Peripheral Vascular Inc for further instructions.
The recalled product
- Product
- Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Biopsy Probe
- Affected units
- 1,585
Distribution
Part of a larger recall action
This product is one of 4 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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