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 about leaks, suction issues, and failure to obtain 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 is classified as FDA Class II, and the product is a medical device where failure to obtain samples represents a risk of harm (diagnostic failure) even though specific injuries are not reported in the source text.
Plain-English summary
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes, which are indicated for use in acquiring tissue for diagnosing breast abnormalities. The recall involves 125,292 units of the product, which is packaged individually in sterile pouches and is intended for single use.
The recall was initiated due to an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. The affected units were distributed worldwide, including nationwide in the United States and Puerto Rico, as well as to numerous foreign countries.
Healthcare providers and consumers should stop using the affected EnCor Breast Biopsy Probes and contact Bard Peripheral Vascular Inc for further instructions or a replacement. The specific lot numbers affected are listed in the official recall documentation.
The recalled product
- Product
- EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7G - REF ECP017G.Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Biopsy Probe
- Affected units
- 125,292
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 (20)
- Lot numbers VTCU0342
- VTCU0343
- VTCU0344
- VTCU0345
- VTCU0346
- VTCU0347
- VTCU0348
- VTCU0349
- VTCU0350
- VTCV0372
- VTCV0373
- VTCV0374
- VTCV0375
- VTCV0376
- VTCV0377
- VTCV0378
- VTCV0379
- VTCV0380
- VTCV0381
- VTCV0382
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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