Home › Device types › EZN
Dilator, Catheter, Ureteral
FDA product code EZN · Class 2 · Gastroenterology, Urology
263
Registered devices
1,115
Adverse events
14
Recalls
56
510(k) clearances
Devices with this code
UroMax Ultra Kit — BOSTON SCIENTIFIC CORPORATIONUroMax Ultra Kit — BOSTON SCIENTIFIC CORPORATIONn.a. — Karl Storz GmbH & Co. KGUroForce® Balloon Dilation Catheter — C. R. Bard, Inc.Bard® X-Force® Balloon Dilation Catheter — C. R. Bard, Inc.n.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGUroForce® Balloon Dilation Catheter — C. R. Bard, Inc.Ascend AQ — COOK INCORPORATEDPorges Coloplast — Coloplast A/SMIP Minimal Invasive PCNL — Karl Storz GmbH & Co. KGNA — BOSTON SCIENTIFIC CORPORATIONCook — COOK INCORPORATEDARMADA — ALLWIN MEDICAL DEVICES, INC.MIP Minimal Invasive PCNL — Karl Storz GmbH & Co. KGBard® X-Force® Balloon Dilation Catheter — C. R. Bard, Inc.Cook — COOK INCORPORATEDColoplast — Coloplast A/SAscend AQ — COOK INCORPORATEDn.a. — Karl Storz GmbH & Co. KGCook — COOK INCORPORATEDBard® X-Force® Balloon Dilation Catheter — C. R. Bard, Inc.Passport Kit — BOSTON SCIENTIFIC CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-05 | Boston Scientific Corporation | 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 inv |
| 2024-03-11 | Coloplast Manufacturing US, LLC | 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 ureter |
| 2007-11-30 | Boston Scientific Corporation | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
| 2007-11-30 | Boston Scientific Corporation | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
| 2007-11-30 | Boston Scientific Corporation | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
| 2007-11-30 | Boston Scientific Corporation | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
| 2007-11-30 | Boston Scientific Corporation | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
| 2007-11-30 | Boston Scientific Corporation | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
| 2007-11-30 | Boston Scientific Corporation | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
| 2007-11-30 | Boston Scientific Corporation | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
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