Boston Scientific Corporation: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter

Hazard

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.

Details from the source

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: 37252 catheters Lot/code info: UDI/DI 08714729187936, Batch Numbers: 60438199, 60453733, 60472577, 60486300, 60500754, 60513563, 60438660, 60459203, 60473158, 60491662, 60507655, 60529457, 60440956, 60465786, 60477280, 60495526, 60507656, 60533641, 60445923, 60465788, 60477281, 60495527, 60511179, 60538216, 60448986, 60467041, 60477282, 60498225, 60511181, 60538217, 60449233, 60467087, 60486299, 60498226, 60512377

UPC codes

08714729187936

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.