Home › Device types › LJE
Catheter, Nephrostomy
FDA product code LJE · Class U · Unknown
381
Registered devices
812
Adverse events
12
Recalls
56
510(k) clearances
Devices with this code
Cook — COOK INCORPORATEDMalecot — COOK INCORPORATEDKolibri — Coloplast A/SKolibri — Coloplast A/SUniversa — COOK INCORPORATEDAmplatz — COOK INCORPORATEDCook — COOK INCORPORATEDPercuflex™ Urinary Diversion Stent Set — BOSTON SCIENTIFIC CORPORATIONRing — COOK INCORPORATEDDawson Mueller — COOK INCORPORATEDAmplatz — COOK INCORPORATEDBander — COOK INCORPORATEDCook — COOK INCORPORATEDBander — COOK INCORPORATEDCook — COOK INCORPORATEDCook — COOK INCORPORATEDCook — COOK INCORPORATEDPercuflex™ Urinary Diversion Stent — BOSTON SCIENTIFIC CORPORATIONLawson — COOK INCORPORATEDUniversa — COOK INCORPORATEDAmplatz — COOK INCORPORATEDAmplatz Type Renal Sheath — BOSTON SCIENTIFIC CORPORATIONBander — COOK INCORPORATEDUltrathane — COOK INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-17 | Olympus Corporation of the Americas | Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon cathe |
| 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 |
| 2021-10-13 | Cook Inc. | Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur i |
| 2020-08-31 | Cook Inc. | The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current I |
| 2020-08-31 | Cook Inc. | The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current I |
| 2019-01-04 | Cook Inc. | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the |
| 2016-10-12 | C.R. Bard, Inc. | Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr. |
| 2016-01-27 | Cook Inc. | Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend AQ Ureteral Dilation Balloon Catheter Set because of |
| 2016-01-27 | Cook Inc. | Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend AQ Ureteral Dilation Balloon Catheter Set because of |
| 2013-05-28 | Boston Scientific Corporation | Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter. |
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