https://plainrecords.com/brand/boston-scientific-scimed/New recalls of Boston Scientific Scimed from FDA, CPSC and NHTSA records.en-ushttps://plainrecords.com/recall/device/z-0440-06/https://plainrecords.com/recall/device/z-0440-06/Wed, 25 Jan 2006 00:00:00 +0000One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. The product, pouch label and carton label are all correct and the correct DFU is in the package.https://plainrecords.com/recall/device/z-0432-06/https://plainrecords.com/recall/device/z-0432-06/Tue, 24 Jan 2006 00:00:00 +0000Some Mach 1 6F Coronary Guide Catheter could be mislabeled in that a few units labeled as Mach 1 6F Kimny Curve style, could contain a Mach 1 6F JR 3.5 curve style and a few units labeled as Mach 1 6F JR 3.5 curve style, could contain a Mach 1 6F Kimny curve style.https://plainrecords.com/recall/device/z-0299-06/https://plainrecords.com/recall/device/z-0299-06/Fri, 23 Dec 2005 00:00:00 +0000Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the vein and causing a tear.https://plainrecords.com/recall/device/z-0931-05/https://plainrecords.com/recall/device/z-0931-05/Sat, 25 Jun 2005 00:00:00 +0000Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.https://plainrecords.com/recall/device/z-0454-05/https://plainrecords.com/recall/device/z-0454-05/Fri, 28 Jan 2005 00:00:00 +0000The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. This condition could have the potential to damage a POBA or Stent Delivery System balloonhttps://plainrecords.com/recall/device/z-1340-04/https://plainrecords.com/recall/device/z-1340-04/Fri, 13 Aug 2004 00:00:00 +0000Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use.https://plainrecords.com/recall/device/z-1052-04/https://plainrecords.com/recall/device/z-1052-04/Tue, 20 Jul 2004 00:00:00 +0000On a few occasions the balloon has failed to deflate within one minute after deployment of the stent.https://plainrecords.com/recall/device/z-0729-04/https://plainrecords.com/recall/device/z-0729-04/Tue, 20 Jul 2004 00:00:00 +0000Some of the catheters may have yellow foreign material in their pigtail tips. The foreign material in the device could cause a stroke or significant damage to organs other than the brain.https://plainrecords.com/recall/device/z-0030-04/https://plainrecords.com/recall/device/z-0030-04/Wed, 15 Oct 2003 00:00:00 +0000Some of the recalled catheters have a component that has levels of pyrogens above specification.https://plainrecords.com/recall/device/z-1189-03/https://plainrecords.com/recall/device/z-1189-03/Fri, 29 Aug 2003 00:00:00 +0000Some of the recalled catheters may be in pouches with incomplete seals.https://plainrecords.com/recall/device/z-1123-03/https://plainrecords.com/recall/device/z-1123-03/Tue, 12 Aug 2003 00:00:00 +0000There is an Increased potential for broken struts of the stents.https://plainrecords.com/recall/device/z-1096-03/https://plainrecords.com/recall/device/z-1096-03/Tue, 12 Aug 2003 00:00:00 +0000Some of the product pouches have holes in the seals.https://plainrecords.com/recall/device/z-0776-03/https://plainrecords.com/recall/device/z-0776-03/Tue, 22 Apr 2003 00:00:00 +0000A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.https://plainrecords.com/recall/device/z-0711-03/https://plainrecords.com/recall/device/z-0711-03/Wed, 09 Apr 2003 00:00:00 +0000The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility.