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COOK INCORPORATED · Model G19085 · UDI-DI 00827002190856

LJE Prescription

510(k) clearances

812

Adverse events (8 deaths)

Recalls

Facilities

Description

Percutaneous Entry Set

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 catheter (BPCN0815). All
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
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 if an affected produc
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 IFU is in process of
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 IFU is in process of
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 flexible tip.
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 a labeling mix-up.
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 a labeling mix-up.
2013-05-28	Boston Scientific Corporation	Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

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Data 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.