CARDINAL HEALTH SMA11LSJH3Recalls & reported problems
Cardinal Health 200, LLC · LAPAROSCOPY D AND C PACK · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195594635237), received between Jun 30, 2022 and Jun 30, 2022 — classified as 1 malfunction.
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
Device problems
- Break1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2022Break; Material Separation; Break
CUSTOMER REPORTED THAT THE CLEAR BALLOON PORTION OF THE 18 FRENCH FOLEY CATHETER, 87-605189, FROM A LAPAROSCOPY DILATION AND CURETTAGE PACK, SMA11LSJH3, CAME APART FROM THE CATHETER AND WAS FOUND IN THE PATIENT¿S BLADDER. THE PIECE WAS FOUND WHEN A ROUTINE CYSTOSCOPY WAS DONE AT THE END OF THE PROCEDURE. THE INTACT PIECE WAS REMOVED. THE PATIENT IS DOING FINE WITH NO PROBLEMS.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 14881029 ↗
Other CURETTE, UTERINE devices
- Sklar Instruments 96-4113Sklar Corporation · CURETTE, UTERINE1 recall0 reports
- AESCULAP ER223RAesculap AG · CURETTE, UTERINE2 reports
- AESCULAP ER402RAesculap AG · CURETTE, UTERINE2 reports
- V. Mueller GL1625Steris Corporation · CURETTE, UTERINE1 report
- V. Mueller GL1600-003Steris Corporation · CURETTE, UTERINE1 report
- Busse Hospital Disposables 284Robert Busse & CO., Inc. · Curette, Uterine1 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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