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Porges Coloplast
Coloplast A/S · Model BD4146 · UDI-DI 05708932727563
EZN
Prescription
10
510(k) clearances
1,112
Adverse events (6 deaths)
14
Recalls
39
Facilities
Description
In-Ka Ureteral Balloon Dilatation Catheter + syringe Balloon Dilation with inflation device, diameter of the balloon 6 mm, body tube length 75 cm, radiopaque stainless-steel rings + Syringe 10 ml
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 investigation determine |
| 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 ureteral dilator packaging |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.