BIOPSYBELL BONE MARROW MSC ASPIRATION KIT-MARROW-STEMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033860036317), received between Jan 15, 2026 and Jan 15, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Break

  IN DATE (B)(6) 2025 OUR DISTRIBUTOR (B)(4) IN THE PERSON OF (B)(6) NOTIFIED OUR CUSTOMER CARE ABOUT AN EVENT OCCURRED WITH A BIOPSYBELL'S NEEDLE BROKEN INTO A PATIENT (TIP OF THE NEEDLE BROKEN). IN DATE 18 DEC 2025 WE RECEIVED THE FOLLOWING INFORMATION FROM THE SAME PERSON: " BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THE FRAGMENT REMAINS WITHIN THE PATIENT. THERE HAVE BEEN NO REPORTS OF IMMEDIATE PATIENT HARM, AND THERE IS CURRENTLY NO INDICATION OF MIGRATION; THE FRAGMENT APPEARS TO. BE SECURELY EMBEDDED. THIS ASSESSMENT REMAINS UNDER EVALUATION. WE ARE IN ACTIVE COMMUNICATION WITH BOTH THE SURGEON AND THE HOSPITAL. AS A PRECAUTIONARY MEASURE, I HAVE OFFERED TO RETRIEVE THE ENTIRE LOT, ALTHOUGH THIS IS BEING PRESENTED AS AN ABUNDANCE OF CAUTION RATHER THAN AN INDICATION OF A BROADER ISSUE. ALL PARTIES HAVE BEEN ADVISED THAT THIS APPEARS TO. BE AN ISOLATED INCIDENT. THE SURGEON HAS BEEN VERY REASONABLE AND HAS CHARACTERIZED THE EVENT AS AN UNUSUAL, UNFORESEEN OCCURRENCE DURING THE EXTRACTION PROCESS. IN THE SAME DAY WE RECEIVED THE FILLED FORM REPORT FROM THE HOSPITAL. IN THIS FORM SOME ADDITIONAL INFORMATION WERE INCLUDED: NAME OF THE PERSON WHO REPORTED THE COMPLAINT: (B)(

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24077672 ↗