Dilator, Catheter, Ureteral
Gastroenterology, Urology · 21 CFR 876.5470
Recent MDR events
1,108 adverse event reports on file
- BARD® X-FORCE® BALLOON DILATION CATHETERJul 11, 2026InjuryC.r. Bard Inc. (covington) -10182331018233-2026-04472
- BARD® X-FORCE® BALLOON DILATION CATHETERJul 10, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04421
- UROMAX ULTRAJul 9, 2026MalfunctionBoston Scientific Corporation2124215-2026-36659
- UROMAX ULTRA KITJul 6, 2026MalfunctionBoston Scientific Corporation2124215-2026-36068
- PERCUTANEOUS NEPHROSTOMY DILATORJun 19, 2026InjuryColoplast A/s9610711-2026-00197
- BARD® X-FORCE® BALLOON DILATION CATHETERJun 17, 2026InjuryC.r. Bard Inc. (covington) -10182331018233-2026-03918
- BARD® X-FORCE® BALLOON DILATION CATHETERJun 4, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-03601
- BARD® X-FORCE® BALLOON DILATION CATHETERApr 28, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-02713
- BARD® X-FORCE® BALLOON DILATION CATHETERApr 14, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-02439
- UROMAX ULTRAApr 10, 2026MalfunctionBoston Scientific Corporation2124215-2026-19576
Event type breakdown
Recalls
14 recall events for this product code
- Boston Scientific CorporationOpen, ClassifiedSep 5, 2025
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN):
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.
Z-2536-2025 · View FDA record ↗ - Coloplast Manufacturing US, LLCOpen, ClassifiedApr 2, 2024
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.
Z-1463-2024 · View FDA record ↗ - Boston Scientific CorporationTerminatedApr 30, 2008
Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, Onset Medical, Boston Scient
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
Z-0905-2008 · View FDA record ↗ - Boston Scientific CorporationTerminatedApr 30, 2008
Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog Number: 255101; Product Number: M0062551010, Onset Medical, Boston Scient
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
Z-0906-2008 · View FDA record ↗ - Boston Scientific CorporationTerminatedApr 30, 2008
Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog Number: 255102; Product Number: M0062551020, Onset Medical, Boston Scient
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
Z-0907-2008 · View FDA record ↗ - Boston Scientific CorporationTerminatedApr 30, 2008
Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Number: 255103; Product Number: M0062551030, Onset Medical, Boston Scient
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
Z-0908-2008 · View FDA record ↗ - Boston Scientific CorporationTerminatedApr 30, 2008
Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog Number: 255104; Product Number: M0062551040, Onset Medical, Boston Scient
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
Z-0909-2008 · View FDA record ↗ - Boston Scientific CorporationTerminatedApr 30, 2008
Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator, Catalog Number: 255105; Product Number: M0062551050, Onset Medical, Boston Scient
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
Z-0910-2008 · View FDA record ↗ - Boston Scientific CorporationTerminatedApr 30, 2008
Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106; Product Number: M0062551060, Onset Medical, Boston Scient
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
Z-0911-2008 · View FDA record ↗ - Boston Scientific CorporationTerminatedApr 30, 2008
Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070, Onset Medical, Boston Scient
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
Z-0912-2008 · View FDA record ↗
Registered firms
66 firms currently registered for this product code
Biomerics Fmi
Athens, TX, US
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
C.r. Bard, Inc.
MADISON, GA, US
Cook Incorporated
ELLETTSVILLE, IN, US
Boston Scientific Corporation
Coventry, RI, US
Cook Incorporated
Spencer, IN, US
Steritec Services, Llc
ATHENS, TX, US
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
C.r. Bard, Inc.
COVINGTON, GA, US
C.r. Bard, Inc.
Queensbury, NY, US
Boston Scientific Corporation
Saint Paul, MN, US
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center
QUINCY, MA, US
Sterigenics Belgium Petit Rechain S.a.
Verviers Liege, BE
Boston Scientific Corporation
Marlborough, MA, US
Karl Storz Endoscopy Canada Ltd.
Mississauga Ontario, CA
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Cook Incorporated
Bloomington, IN, US
Boston Scientific Limited
GALWAY, IE
510(k) clearances
56 clearances for this product code
- Urotronic, Inc.May 22, 2025
K250910 · Optilume® High Pressure Urological Balloon Dilation Catheter
- Allwin Medical Devices, Inc.May 5, 2023
K220781 · ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
- Coloplast Corp.Jun 11, 2020
K201007 · In-Ka Ureteral Balloon Dilatation Catheter
- Dornier Medtech America, Inc.Dec 6, 2019
K190612 · EQUINOX Balloon Dilatation Catheter
- Cook IncorporatedJul 17, 2018
K173654 · Ureteral Dilator Sets, Ureteral Dilators
- Cook IncorporatedMay 24, 2018
K180756 · Safety Wire Guide Introducer
- Cook IncorporatedMay 2, 2018
K180028 · Cook 810 Set, Desilets-Hoffman Introducer Set
- Cook IncorporatedApr 19, 2018
K172588 · Balloon Catheter and Balloon Ureteral Dilator Set