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SOF-CURL SSC6024Recalls & reported problems

Gyrus ACMI, LLC · 6.0 Fr. (2mm) x 24cm SOF-CURL URETERAL STENT · Class 2 · Implant

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 00821925031678), received between Mar 5, 2021 and Mar 5, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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.

Most reported problems

Device problems

  • Device Damaged Prior to Receipt by User1
  • Device Damaged Prior to Use1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionMar 5, 2021Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use

    IT WAS REPORTED THAT DURING RECEIPT INSPECTION, THE USER FACILITY RECEIVED A DAMAGED PRODUCT. THE BOX AND THE CONTENTS WERE FOUND DAMAGED. IN ADDITION, THE CUSTOMER ADVISED THEY ORDERED A QUANTITY OF 25 AND ONLY RECEIVED A QUANTITY OF 13 . THE CUSTOMER ADVISED THAT THE OUTSIDE OF THE BOX SAID 25 QUANTITY BUT THERE WAS ONLY 13 QUANTITY. CUSTOMER EXPLAINED THAT THE OUTSIDE BOX DID NOT REFLECT AS MUCH DAMAGE AS THE INSIDE BOX. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT REPORTED. NO USER INJURY REPORTED.

    Patient problems: No Patient Involvement

    MAUDE report 11421181 ↗

Other Stent, Ureteral devices

All Stent, Ureteral devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.