Boston Scientific Corporation: Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

Hazard

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Details from the source

Reason for recall: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. Distribution: US Nationwide distribution in the state of Indiana. Quantity: 3783 units Lot/code info: GTIN 08714729202516, Lot/Batch Numbers: 25761345, 26059398, 26138707, 26599635, 26599636, 25761344, 25964138, 25964139, 25964480, 25964481, 25964482, 26059399, 26130252, 26130253, 26138708, 26277183, 26599634, 26599637, 26746100, 26746101, 26746102, 26746103, 26891769, 26891770, 26997421, 26997422, 27129310, 27129311, 27144692, 27779956, 27779958, 28384662, 28502672, 28676780, 28832480, 28832482, 28886617, 28886618, 28886619, 28955942, 27144691, 27269744, 27585414, 28007176, 28676579, 28886800

UPC codes

08714729202516

Source

Official record: FDA (Device enforcement) ↗

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