ENCOR® ENCFINSERT10GRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741086465), received between Mar 21, 2017 and Sep 19, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Accessory Incompatible” (4 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Device Emits Odor; Device Emits Odor

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE PERFORMED WITH THE ENCORE INSTRUMENT. DURING THE PROCEDURE, THE ENCORE CODES WERE FOUND IN BOXES THAT EMITTED A FOUL ODOR, CAUSING ILLNESS AMONG THE LABELING STAFF, INCLUDING SYMPTOMS SUCH AS NAUSEA, GENERAL MALAISE, AND DIARRHEA. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098792 ↗
• MalfunctionSep 19, 2025Device Emits Odor; Device Emits Odor

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE PERFORMED WITH THE ENCORE INSTRUMENT. DURING THE PROCEDURE, THE ENCORE CODES WERE FOUND IN BOXES THAT EMITTED A FOUL ODOR, CAUSING ILLNESS AMONG THE LABELING STAFF, INCLUDING SYMPTOMS SUCH AS NAUSEA, GENERAL MALAISE, AND DIARRHEA. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098444 ↗
• MalfunctionOct 4, 2023Accessory Incompatible; Difficult to Remove; Accessory Incompatible; Difficult to Remove

  IT WAS REPORTED THAT DURING A STEREOTACTIC BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE GUIDE WAS ALLEGEDLY TOO TIGHT AND TOOK SO LONG TO REMOVE THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17866653 ↗
• MalfunctionOct 4, 2023Accessory Incompatible; Difficult to Remove; Accessory Incompatible; Difficult to Remove

  IT WAS REPORTED THAT DURING A STEREOTACTIC BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE GUIDE WAS ALLEGEDLY TOO TIGHT AND TOOK SO LONG TO REMOVE THE NEEDLE. IT WAS FURTHER REPORTED THAT THE NEEDLE GUIDE WAS TOO SMALL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17866438 ↗
• MalfunctionJun 1, 2023Accessory Incompatible; Difficult to Remove; Accessory Incompatible; Difficult to Remove

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE WAS ALLEGEDLY DIFFICULT TO BE PASSED THROUGH THE GUIDE. IT WAS FURTHER REPORTED THAT THE GUIDE WAS ALLEGEDLY DIFFICULT TO BE REMOVED. IT WAS ALSO REPORTED THAT THE THERE WAS AN ASYMMETRIC FLANGE INSIDE THE GUIDE WHICH LUGS AND SITS ALMOST FIRMLY OVER SEVERAL PARTS OF THE NEEDLE. IT WAS ALSO REPORTED THAT RESISTANCE WAS FELT WHEN PULLING THE FLANGE OFF. FURTHERMORE, AFTER THE GUIDE WAS FITTED, DEPENDING ON THE EXTENT THERE WAS TIGHTNESS AROUND THE BARBS. REPORTEDLY THE FLANGE/EDGE WAS COMPLETELY CLEAR AND SHARPLY DEFINED AND IT WAS SPREAD OVER APPROXIMATELY HALF THE CIRCLE RESULTING IN NOISE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037026 ↗
• MalfunctionJun 1, 2023Accessory Incompatible; Difficult to Remove; Accessory Incompatible; Difficult to Remove

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE WAS ALLEGEDLY DIFFICULT TO BE PASSED THROUGH THE GUIDE. IT WAS FURTHER REPORTED THAT THE GUIDE WAS ALLEGEDLY DIFFICULT TO BE REMOVED. IT WAS ALSO REPORTED THAT THE THERE WAS AN ASYMMETRIC FLANGE INSIDE THE GUIDE WHICH LUGS AND SITS ALMOST FIRMLY OVER SEVERAL PARTS OF THE NEEDLE. IT WAS ALSO REPORTED THAT RESISTANCE WAS FELT WHEN PULLING THE FLANGE OFF. FURTHERMORE, AFTER THE GUIDE WAS FITTED, DEPENDING ON THE EXTENT THERE WAS TIGHTNESS AROUND THE BARBS. REPORTEDLY THE FLANGE/EDGE WAS COMPLETELY CLEAR AND SHARPLY DEFINED AND IT WAS SPREAD OVER APPROXIMATELY HALF THE CIRCLE RESULTING IN NOISE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036980 ↗
• MalfunctionJul 20, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO BIOPSY PROCEDURE, THE STERILIZED PACKAGE WAS ALLEGEDLY FOUND TO BE DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12195111 ↗
• MalfunctionNov 8, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER COMPLETING A STEREOTACTIC-GUIDED BIOPSY, WHEN NEEDLE WAS REMOVED, ALLEGEDLY A PLASTIC PIECE WAS FOUND IN THE NEEDLE GUIDE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8053036 ↗
• MalfunctionAug 29, 2017Difficult To Position; Device Markings/Labelling Problem; Difficult To Position; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR A STEREOTACTIC BREAST BIOPSY, THE PROBE ALLEGEDLY WAS UNABLE TO GO THROUGH THE NEEDLE GUIDE INSERT TO POSITION FOR THE PROCEDURE. REPORTEDLY, ANOTHER INSERT WAS ABLE TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6827338 ↗
• MalfunctionMar 21, 2017Difficult To Position; Device Markings/Labelling Problem; Difficult To Position; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A STEREOTACTIC BREAST BIOPSY, THE BIOPSY NEEDLE GUIDE WAS ALLEGEDLY TO NARROW AND THE PROBE WAS UNABLE TO INSERT FOR THE PROCEDURE. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6420511 ↗