Catheter, Nephrostomy

Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit

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 other components in the kits were correctly included and packaged in the kit.

Boston Scientific NephroMax 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.

UltraxxTM Nephrostomy Balloon Set

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. Cook Medical has received reports of packages labeled as Ultraxx" Nephrostomy Balloon Set actually containing the Ascend AQ Ureteral Dilation Balloon Catheter Set and vice versa.

Ascend AQ Ureteral Dilation Balloon Catheter Set

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. Cook Medical has received reports of packages labeled as Ultraxx" Nephrostomy Balloon Set actually containing the Ascend AQ Ureteral Dilation Balloon Catheter Set and vice versa.

NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144

Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164

Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon;

Mislabeled: Outer box unit has correct part number but product is incorrectly identiified as a Percutaneous Tract Kit with Nephromax Balloon. The box actually contains a Percutaneous Tract Kit with Amplatz Dilator and Sheath Kit

Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5

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 being updated and will be provided with orders placed following implementation.

Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail cathete

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 being updated and will be provided with orders placed following implementation.

X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081

Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.