Centra 00711250Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00724995180645), received between Apr 4, 2024 and Jul 16, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026Insufficient Device Problem Information

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25845360 ↗
• MalfunctionJul 14, 2026Failure to Cut

  Patient problems: Laceration(s)

  MAUDE report 25813159 ↗
• MalfunctionJul 2, 2026Mechanical Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE CENTRA BIOPSY FORCEPS WERE "PULLING THE TISSUE" RESULTING IN BLEEDING. NO REPORT OF PROCEDURE DELAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25695613 ↗
• MalfunctionJun 26, 2026Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED DURING PATIENT PROCEDURES WITH THE USE OF A CENTRA DISPOSABLE BIOPSY FORCEPS, THE USER NOTED BLEEDING AT THE BIOPSY SITE, TEARING OF THE TISSUE, AND DIFFICULTY REMOVING THE TISSUE FROM THE DEVICE TEETH. THE PATIENT PROCEDURES WERE COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25634899 ↗
• MalfunctionMay 22, 2026Difficult to Remove

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR LUMIFLEX BALLOON DILATION CATHETER WAS DEFLATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY AFTER USER FACILITY PERSONNEL REMOVED THE SCOPE AND BALLOON TOGETHER AND CUT THE CATHETER TO ALLOW IT TO BE FULLY EXTRACTED FROM THE WORKING CHANNEL. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25254635 ↗
• MalfunctionMay 21, 2026No Apparent Adverse Event

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE CENTRA DISPOSABLE BIOPSY FORCEPS WERE NOT ABLE TO "BITE" THE TISSUE SUBSEQUENTLY CAUSING A PERFORATION. THE PERFORATION WAS CLOSED WITH CLIPS AND USER FACILITY PERSONNEL ELECTED TO CONTINUE THE PROCEDURE WITH THE DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243228 ↗
• MalfunctionApr 22, 2026Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THEIR BIOPSY FORCEPS WERE NOT CUTTING AS DESIRED CAUSING TISSUE TEARING AND SUBSEQUENT BLEEDING. MEDICAL TREATMENT WAS ADMINISTERED AND THE BLEEDING WAS CONTROLLED USING A HEMOCLIP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24952925 ↗
• MalfunctionApr 16, 2026Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES, THE CENTRA DISPOSABLE BIOPSY FORCEPS IS "TEARING THE TISSUE" RESULTING IN BLEEDING. THE PATIENT PROCEDURES WERE COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24899281 ↗
• MalfunctionApr 16, 2026Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE CENTRA DISPOSABLE BIOPSY FORCEPS CAUSED "BLEEDING" AND "TEARING". USER FACILITY PERSONNEL UTILIZED A HEMOSTASIS CLIP AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24899280 ↗
• MalfunctionMar 5, 2025Failure to Cut; Failure to Cut

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THEIR BIOPSY FORCEPS WERE NOT CUTTING AS DESIRED RESULTING IN TEARING OF THE TISSUE. MEDICAL TREATMENT WAS ADMINISTERED WITH CLIPS BEING APPLIED.

  Patient problems: Laceration(s)

  MAUDE report 21529658 ↗
• MalfunctionOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR CENTRA BIOPSY FORCEPS WERE "TEARING TISSUE." NO REPORT OF PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482991 ↗
• MalfunctionSep 26, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR CENTRA BIOPSY FORCEPS HAD A "BROKEN HANDLE" AND WERE "STIFF." THESE ISSUES RESULTED IN REPORTED "INSTANCES OF THE FORCEPS TEARING THE MUCOSA."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20316281 ↗
• MalfunctionJul 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THEIR BIOPSY FORCEPS WERE NOT CUTTING PROPERLY RESULTING IN TEARING OF THE TISSUE. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED. NO REPORT OF PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731422 ↗
• MalfunctionApr 4, 2024Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT THEIR CENTRA BIOPSY FORCEPS SERRATED NEEDLE WAS PULLING THE TISSUE AND NOT CUTTING CLEANLY, WHICH LED TO EXTRA BLEEDING. THE USER HAD TO RELEASE THE TISSUE MULTIPLE TIMES; HOWEVER, THE PROCEDURE WAS COMPLETED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19042450 ↗