Boston Scientific Corporation: Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, 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: 2184 units Lot/code info: GTIN 08714729244318, Lot/Batch Numbers: 25823581, 26059696, 26130255, 26277192, 26746112, 26984240, 27241920, 25823580, 25964485, 25964486, 25964487, 26059694, 26130254, 26277190, 26277191, 26599708, 26599709, 26599710, 26599711, 26599712, 26746113, 26984241, 26984253, 27203538, 27203539, 27379022, 28384669, 28632346, 28632344

UPC codes

08714729244318

Source

Official record: FDA (Device enforcement) ↗

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