N/A 4382ARecalls & reported problems
Carefusion 2200, Inc · Soft Tissue Biopsy Tray · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403108501), received between Jun 1, 2026 and Jun 22, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
- Illegible Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2026Illegible Information
IT WAS REPORTED THAT ON (B)(6) 2026, THE SOFT TISSUE BIOPSY PRODUCT WAS IDENTIFIED DAMAGED, CONCEALED DAMAGED, AND THE LOT AND EXPIRATION DATE ARE UNREADABLE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25585842 ↗MalfunctionJun 1, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE PRODUCT CAME IN WITH FILM ALL OVER THE PACKAGE, LIKE A DETERGENT. DURING FOLLOW UP IT WAS FURTHER REPORTED THE PRODUCT WAS IN REPACK BOX AND THE PACKAGES WERE RECEIVED WITH LIQUID SUBSTANCE. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25348718 ↗
Other Tray, surgical, needle devices
- N/A 4380Carefusion 2200, Inc · Tray, surgical, needle2 reports
- JAMSHIDI SN1015XCarefusion 2200, Inc · Tray, surgical, needle1 report
- JAMSHIDI SN7016XCarefusion 2200, Inc · Tray, surgical, needle1 report
- N/A 4382SPCarefusion 2200, Inc · Tray, surgical, needle1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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