TECOFLEX 5607026Recalls & reported problems
Gyrus ACMI, LLC · 7.0FR (2.3mm) X 26 cm DOUBLE PIGTAIL URETERAL STENT HYDROPHILIC COATED TECOFLEX · Class 2 · Implant
Data updated Oct 16, 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 00821925004078), received between May 9, 2023 and May 9, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).
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 16, 2026.
Most reported problems
Device problems
- Delivered as Unsterile Product2
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.
MalfunctionMay 9, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE CUSTOMER REPORTED THAT DURING RECEIPT INSPECTION OF THE DOUBLE PIGTAIL URETERAL STENT, ¿THE OUTER PACKAGING WAS BENT, AND THE SEAL WAS BROKEN¿. THE STERILITY OF THE DEVICE HAS BEEN COMPROMISED. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED. TWO DEVICES WITH THE SAME ISSUE WERE REPORTED BY THE CUSTOMER. THIS REPORT IS FOR DEVICE 2 OF 2. THE FIRST DEVICE IS BEING REPORTED ON MEDWATCH PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16896163 ↗MalfunctionMay 9, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE CUSTOMER REPORTED THAT DURING RECEIPT INSPECTION OF THE DOUBLE PIGTAIL URETERAL STENT, ¿THE OUTER PACKAGING WAS BENT, AND THE SEAL WAS BROKEN¿. THE STERILITY OF THE DEVICE HAS BEEN COMPROMISED. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED. TWO DEVICES WITH THE SAME ISSUE WERE REPORTED BY THE CUSTOMER. THIS REPORT IS FOR DEVICE 1 OF 2. THE SECOND DEVICE IS BEING REPORTED ON MEDWATCH PATIENT IDENTIFIER (B)(6) .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16896077 ↗
Other Stent, Ureteral devices
- Bard® InLay Optima® Ureteral Stent 788426C. R. Bard, Inc. · STENT, URETERAL1 recall100 reports
- Bard® InLay Optima® Ureteral Stent 788626C. R. Bard, Inc. · STENT, URETERAL122 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777626C. R. Bard, Inc. · STENT, URETERAL118 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777426C. R. Bard, Inc. · STENT, URETERAL108 reports
- Bard® InLay® Ureteral Stent 778626C. R. Bard, Inc. · STENT, URETERAL100 reports
- Percuflex™ Plus M0061752530Boston Scientific Corporation · STENT, URETERAL1 death99 reports
- Contour VL™ M0061801560Boston Scientific Corporation · STENT, URETERAL1 recall45 reports
- Polaris™ Ultra M0061921330Boston Scientific Corporation · STENT, URETERAL71 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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