An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Reason for recall: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining. Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions. Quantity: 116091 catheters Lot/code info: UDI/DI 08714729187820, Batch Numbers: 60427721, 60437784, 60456288, 60473154, 60481598, 60500737, 60427722, 60443032, 60461431, 60473157, 60481599, 60505121, 60427723, 60443033, 60462014, 60474023, 60481600, 60512236, 60427724, 60443034, 60463401, 60474083, 60481601, 60512384, 60427725, 60443035, 60463402, 60474084, 60488294, 60512385, 60427726, 60443036, 60463600, 60474085, 60488295, 60521834, 60430878, 60443903, 60463954, 60476445, 60488296, 60521835, 60430926, 60443904, 60463955, 60477256, 60488297, 60521836, 60430927, 60443905, 60463967, 60479456, 60488298, 60522587, 60430928, 60443906, 60463974, 60479457, 60492673, 60522901, 60432308, 60443907, 60464492, 60479458, 60492674, 60522902, 60432309, 60446725, 60470527, 60479459, 60492675, 60525059, 60432310, 60448203, 60470528, 60479460, 60492676, 60525077, 60434240, 60448204, 60470530, 60479461, 60492677, 60527362, 60434481, 60448205, 60470531, 60481596, 60498229, 60527363, 60436641, 60452064, 60472576, 60481597, 60498230, 60533639, 60538215
08714729187820
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.