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TECOFLEX 5606026Recalls & reported problems

Gyrus ACMI, LLC · 6.0FR(2mm) X 26 cm DOUBLE PIGTAIL URETERAL STENT HYDROPHILIC COATED TECOFLEX · 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 00821925004764), received between Mar 22, 2021 and Mar 22, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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

  • Delivered as Unsterile Product1
  • Device Damaged Prior to Use1

Patient problems

  • 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.

  • MalfunctionMar 22, 2021Delivered as Unsterile Product; Device Damaged Prior to Use; Delivered as Unsterile Product; Device Damaged Prior to Use

    AS REPORTED FOR THIS EVENT, THE DEVICE WAS OBSERVED TO BE CRIMPED WITH A HOLE IN THE PACKAGING UPON RECEIPT. THE DEVICE WAS NOT USED. THE DEVICE WAS NOT REMOVED FROM THE BOX. THERE IS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11543110 ↗

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.