EnCor EnCompass™ ENCP10GRecalls & reported problems
Bard Peripheral Vascular, Inc. · EnCor EnCompass™ Breast Biopsy and Tissue Removal System Probe – 10G, TriConcave™ · Class 2
All models of EnCor EnCompass (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741234170), received between May 14, 2026 and May 14, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K252681); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026Device Contamination with Chemical or Other Material
ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A BIOPSY PROCEDURE USING AN ENCOR ENCOMPASS PROBE. PRIOR TO THE PROCEDURE, THE PLASTIC PIECES FOUND ON NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25167905 ↗MalfunctionMay 14, 2026Device Contamination with Chemical or Other Material
ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A BIOPSY PROCEDURE USING AN ENCOR ENCOMPASS PROBE. PRIOR TO THE PROCEDURE, THE PLASTIC PIECES FOUND ON NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25167746 ↗MalfunctionMay 14, 2026Device Contamination with Chemical or Other Material
ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A BIOPSY PROCEDURE USING AN ENCOR ENCOMPASS PROBE. PRIOR TO THE PROCEDURE, THE PLASTIC PIECES FOUND ON NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25167739 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K252681. One submission often covers many models, so check the product and lot details in each record.
- Z-3275-2026 · Aug 20, 2026 · Open, ClassifiedEnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software
Other Instrument, biopsy devices
- MAX-CORE MC1616Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall4,258 reports
- ENCOR® ECP017GSenorx, Inc. · INSTRUMENT, BIOPSY1 recall4,186 reports
- MAX-CORE MC1820Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall2,404 reports
- MAX-CORE MC1816Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall1 death848 reports
- MAX-CORE MC1410Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall399 reports
- MAX-CORE MC1610Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall394 reports
- ENCOR® ECP0110GVSenorx, Inc. · INSTRUMENT, BIOPSY392 reports
- ENCOR® ECP0110GSenorx, Inc. · INSTRUMENT, BIOPSY390 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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