T-Lok™ Bone Marrow Biopsy Needle DBMNJ0806TLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333001569), received between Apr 21, 2022 and Apr 21, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2022Product Quality Problem

  HEMATOLOGIST DR. (B)(6) CALLED ME YESTERDAY REGARDING POORER QUALITY OF THE BONE MARROW NEEDLES OVER LONGER TIME. HE HAS BEEN USING OUR NEEDLES FOR AT LEAST 15 YEARS, AND ONLY US, 150-200 NEEDLES PER YEAR.(DBMNJ0806 MOSTLY). IN A NATIONAL STUDY A WHILE AGO, ÅLESUND RECEIVED THE HIGHEST SCORE ON BIOPSY QUALITY. THEY MEASURED LENGTH THICKNESS, AND THE PATHOLOGIST'S DESCRIPTION AMONG OTHER THINGS. NOW THEY MUST USE MORE FORCE TO GET THROUGH THE MARROW. UNISON FROM 5 DOCTORS, INCLUDING HIMSELF. A FEMALE DOCTOR IS NO LONGER ABLE TO TAKE BIOPSIES DUE TO LACK OF POWER. SHE BLAMES HER AGE A BIT, BUT THAT CAN´T BE THE EXPLANATION. 2. THE PATHOLOGISTS DESCRIBE THE BIOPSY AS MORE COMPRESSED THAN BEFORE. THIS CAUSES FRACTURES IN THE MATERIAL AND THE DIAGNOSIS IS MADE MORE DIFFICULT. APRIL 21TH; HE WILL COMPARE TODAY NEEDLES WITH OLDER NEEDLES PRODUCED IN 2018 AND 2019 WE HOPE TO GET CLOSER TO THE PROBLEM IN THIS WAY. I WILL RETURN SOME NEEDLE AND SOME OLD NEEDLE TO COMPARE AFTER THE MEETING APRIL21.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14165208 ↗
• MalfunctionApr 21, 2022Product Quality Problem

  HEMATOLOGIST DR. (B)(6) CALLED ME YESTERDAY REGARDING POORER QUALITY OF THE BONE MARROW NEEDLES OVER LONGER TIME. HE HAS BEEN USING OUR NEEDLES FOR AT LEAST 15 YEARS, AND ONLY US, 150-200 NEEDLES PER YEAR.(DBMNJ0806 MOSTLY). IN A NATIONAL STUDY A WHILE AGO, ÅLESUND RECEIVED THE HIGHEST SCORE ON BIOPSY QUALITY. THEY MEASURED LENGTH THICKNESS, AND THE PATHOLOGIST'S DESCRIPTION AMONG OTHER THINGS. NOW THEY MUST USE MORE FORCE TO GET THROUGH THE MARROW. UNISON FROM 5 DOCTORS, INCLUDING HIMSELF. A FEMALE DOCTOR IS NO LONGER ABLE TO TAKE BIOPSIES DUE TO LACK OF POWER. SHE BLAMES HER AGE A BIT, BUT THAT CAN´T BE THE EXPLANATION. 2. THE PATHOLOGISTS DESCRIBE THE BIOPSY AS MORE COMPRESSED THAN BEFORE. THIS CAUSES FRACTURES IN THE MATERIAL AND THE DIAGNOSIS IS MADE MORE DIFFICULT. (B)(6); HE WILL COMPARE TODAY NEEDLES WITH OLDER NEEDLES PRODUCED IN 2018 AND 2019 WE HOPE TO GET CLOSER TO THE PROBLEM IN THIS WAY. I WILL RETURN SOME NEEDLE AND SOME OLD NEEDLE TO COMPARE AFTER THE MEETING APRIL21.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14165176 ↗