Trek TKM1110Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741201370), received between Sep 11, 2023 and Aug 19, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Break; Failure to Obtain Sample

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50315566 ↗
• MalfunctionAug 19, 2026Break; Failure to Obtain Sample

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50315565 ↗
• MalfunctionMay 25, 2026Break; Failure to Obtain Sample

  ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING TREK BONE MARROW BIOPSY KIT. DURING THE PROCEDURE, THE CANNULA CRACKED WHILE ATTEMPTING TO ASPIRATE, AND ASPIRATION COULD NOT BE PERFORMED. ADDITIONALLY, IT WAS REPORTED THAT THE CANULA WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25268885 ↗
• MalfunctionOct 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ON (B)(6) 2025, A PATIENT UNDERWENT BONE BIOPSY PROCEDURE USING TREK BONE MARROW KIT INSTRUMENT. PRIOR TO THE PROCEDURE THERE WAS A BUG CRAWLING AROUND THE DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288623 ↗
• MalfunctionSep 10, 2025Break; Crack; Failure to Obtain Sample; Break; Crack; Failure to Obtain Sample

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE TREK BONE MARROW. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE ALLEGEDLY FAILED TO OBTAIN THE SAMPLE, AND THE SEAL WAS FOUND BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23013117 ↗
• MalfunctionJul 30, 2025Crack; Difficult to Remove; Material Perforation; Device-Device Incompatibility; Difficult or Delayed Separation; Crack; Difficult to Remove; Material Perforation; Device-Device Incompatibility; Difficult or Delayed Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT A BONE MARROW BIOPSY PROCEDURE USING THE TREK BONE MARROW BIOPSY SYSTEM, THE BLUE HUB OF THE NEEDLE HAD SEEMED TO BE TOO LARGE TO CLICK INTO PLACE ON THE STERILE SLEEVE. FURTHER, THE NEEDLE WAS UNABLE TO REMOVE FROM THE QUICK CONNECT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666184 ↗
• MalfunctionJun 26, 2025Material Separation; Difficult or Delayed Separation; Material Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A DEMO OF A BONE MARROW BIOPSY PROCEDURE, REPORTED THAT THE QUICK CONNECT HUB WAS DIFFICULT TO REMOVE FROM THE DRIVER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22334220 ↗
• MalfunctionJun 10, 2025Difficult to Remove; Failure to Obtain Sample; Device-Device Incompatibility; Difficult or Delayed Separation; Difficult to Remove; Failure to Obtain Sample; Device-Device Incompatibility; Difficult or Delayed Separation

  A PATIENT UNDERWENT A BONE MARROW BIOPSY PROCEDURE, THE DOCTOR COULDN'T GET OUT OF THE PATIENT. THE PHYSICIAN HAD TO ABORT THE PROCEDURE AND START OVER BECAUSE HE COULDN'T GET THE EJECTOR ROD OUT OF THE EJECTOR GUIDE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174656 ↗
• MalfunctionJun 10, 2025Difficult to Remove; Failure to Obtain Sample; Device-Device Incompatibility; Difficult or Delayed Separation; Difficult to Remove; Failure to Obtain Sample; Device-Device Incompatibility; Difficult or Delayed Separation

  A PATIENT UNDERWENT A BONE MARROW BIOPSY PROCEDURE, THE DOCTOR COULDN'T GET OUT OF THE PATIENT. THE PHYSICIAN HAD TO ABORT THE PROCEDURE AND START OVER BECAUSE HE COULDN'T GET THE EJECTOR ROD OUT OF THE EJECTOR GUIDE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174486 ↗
• MalfunctionApr 17, 2025Break; Crack; Failure to Obtain Sample; Break; Crack; Failure to Obtain Sample

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A BONE BIOPSY PROCEDURE USING TREK BONE MARROW BIOPSY KIT. DURING THE PROCEDURE, CANNULA ALLEGEDLY BROKE AND AUDIBLE BREAK HEARD. REPORTEDLY, THERE WAS DIFFICULTY TO PULL ASPIRATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855744 ↗
• MalfunctionFeb 7, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING A BONE BIOPSY PROCEDURE, THE CANNULA ALLEGEDLY BROKE WHEN TRIED TO ASPIRATE THE MARROW. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21330501 ↗
• MalfunctionJan 22, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING A BONE MARROW BIOPSY PROCEDURE, THE CANNULA ALLEGEDLY BROKE BUT NO CRACKING SOUND THIS TIME. IT WAS FURTHER REPORTED THAT THE HEALTHCARE PROFESSIONAL TRIED TO PULL ASPIRATE WITH NEEDLE BUT IT BUBBLED UNTIL ALL SUCTION WAS LOST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21212298 ↗
• MalfunctionJul 5, 2024Break; Crack; Failure to Obtain Sample; Break; Crack; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BONE MARROW BIOPSY PROCEDURE, THE BLUE PLASTIC HUB ALLEGEDLY DID NOT PROVIDE ADEQUATE SUCTION TO DRAW UP MARROW. IT WAS FURTHER REPORTED THAT THE DOCTOR TIGHTENED THE SYRINGE TO GET THE NEEDLE TO SUCTION, AND THE NEEDLE WAS ALLEGEDLY CRACKED. FURTHERMORE, THE NEEDLE WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19677945 ↗
• MalfunctionApr 17, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO THE BONE BIOPSY PROCEDURE, A HAIR WAS ALLEGEDLY FOUND INSIDE THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122889 ↗
• MalfunctionMar 1, 2024Difficult to Remove; Material Perforation; Premature Separation; Difficult to Remove; Material Perforation; Premature Separation

  IT WAS REPORTED THAT DURING A BONE MARROW BIOPSY PROCEDURE, QUICK CONNECT ALLEGEDLY LOST CONNECTION AND DISCONNECTED FROM THE NEEDLE. IT WAS FURTHER REPORTED THAT THEY ALLEGEDLY HAD TO MANUALLY TWIST/ PULL THE CANNULA OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18814825 ↗
• MalfunctionSep 11, 2023Difficult to Remove; Difficult or Delayed Separation; Difficult to Remove; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A BONE MARROW BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY DIDN'T COME OFF FROM THE DRIVER. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ALLEGEDLY DIFFICULT TO BE REMOVED OUT OF THE BODY. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17718161 ↗