Dilator, Catheter, Ureteral
FDA adverse event reports and recall history for dilator, catheter, ureteral (product code EZN), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,103
- Deaths
- 6
- Injuries
- 271
- Malfunctions
- 811
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-09-05Open, ClassifiedUnder Investigation by firm
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240, 6. M0062251260, 7. M0062251290, 8. M0062251300, 9. M0062251310. 10. M0062251350, 11. M0062251360, 12. M0062251370. (Urology)
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
- 2024-04-02Open, ClassifiedUnder Investigation by firm
Ureteral dilator, REF RBD014
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.
- 2008-04-30TerminatedDevice Design
Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, Onset Medical, Boston Scientific Corp., Natick, MA 01760
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- 2008-04-30TerminatedDevice Design
Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog Number: 255101; Product Number: M0062551010, Onset Medical, Boston Scientific Corp., Natick, MA 01760
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- 2008-04-30TerminatedDevice Design
Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog Number: 255102; Product Number: M0062551020, Onset Medical, Boston Scientific Corp., Natick, MA 01760
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- 2008-04-30TerminatedDevice Design
Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Number: 255103; Product Number: M0062551030, Onset Medical, Boston Scientific Corp., Natick, MA 01760
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- 2008-04-30TerminatedDevice Design
Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog Number: 255104; Product Number: M0062551040, Onset Medical, Boston Scientific Corp., Natick, MA 01760
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- 2008-04-30TerminatedDevice Design
Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator, Catalog Number: 255105; Product Number: M0062551050, Onset Medical, Boston Scientific Corp., Natick, MA 01760
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- 2008-04-30TerminatedDevice Design
Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106; Product Number: M0062551060, Onset Medical, Boston Scientific Corp., Natick, MA 01760
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- 2008-04-30TerminatedDevice Design
Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070, Onset Medical, Boston Scientific Corp., Natick, MA 01760
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
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