ENCOR ENSPIRE® DS4001Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741086090), received between Apr 6, 2018 and Oct 24, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Emits Odor” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE ENCOR ENSPIRE CASSETTE. DURING THE PROCEDURE, THE DEVICE ALLEGEDLY HAD A FLUID LEAK. THERE WERE NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377192 ↗
• MalfunctionSep 22, 2025Device Emits Odor; Device Emits Odor

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ENCORE INSTRUMENT. DURING THIS 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 REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23106708 ↗
• MalfunctionSep 19, 2025Device Emits Odor; Device Emits Odor

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ENCORE INSTRUMENT. DURING THIS 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. HOWEVER, THERE WERE NO REPORTED INJURIES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099501 ↗
• MalfunctionSep 19, 2025Device Emits Odor; Device Emits Odor

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ENCORE INSTRUMENT. DURING THIS 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. HOWEVER, THERE WERE NO REPORTED INJURIES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099480 ↗
• MalfunctionJul 15, 2025Missing Information; Missing Information

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ENCOR ENSPIRE CASSETTE. PRIOR TO THE PROCEDURE, IT WAS NOTICED THAT BOTH THE EXTERNAL AND INTERNAL PACKAGES WERE MISSING THE MANUFACTURING DATE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505404 ↗
• MalfunctionAug 19, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A PREPARATION FOR BIOPSY, WHITE POWDER WAS ALLEGEDLY FOUND AT THE CONNECTION PART OF SUCTION RINSE TUBE CASSETTE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342776 ↗
• MalfunctionJun 24, 2021Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY SELF-ACTIVATED. IT WAS FURTHER REPORTED THAT UPON PULING OUT THE SAMPLE TRAY, THERE WAS STRONG RESISTANCE FELT UNDER NEGATIVE PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12056972 ↗
• MalfunctionNov 23, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A PREPARATION FOR BIOPSY, WHITE POWDER WAS ALLEGEDLY FOUND AT THE CONNECTION PART OF SUCTION RINSE TUBE CASSETTE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10883276 ↗
• MalfunctionApr 6, 2018Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR A BIOPSY, THE INDIVIDUAL CASSETTE PACKAGE WAS ALLEGEDLY FOUND WITH THE STERILE WRAPPING OPENED. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7404045 ↗