Recall Z-0935-2008 ยท DQO Catheter, Intravascular, Diagnostic
Boston Scientific
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-301. 6F MULTI PIT 124 (Single Pack). Distal Curve FL4, FR4, PIG 145. 100 and 110 cm Length. Made in Mexico: Parque industrial Le Mesa, Tijuana, Baja California 22050 MEX. Boston Scientific Corporation, Nati
| Date | Jan 31, 2008 (initiated Nov 20, 2007) |
| Status | Terminated |
| Reason | Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | The firm sent an Urgent Medical Device Recall letter dated 11/20/2007, to all affected hospitals. The letter describes the defect with the catheters and Product Table information including UPNs, Catalog Numbers, Lot/Batch Numbers and Product Descriptions. The firm requests that further distribution or use of any remaining product affected by the recall should cease immediately. ****IMPORTANT INFORMATION: If it is a practice of the hospital to remove product from the outer carton and store on shelves in the inner-pouch only. Users are to review the Product Table carefully and consider both |
| Quantity | 211 single units |
| Distribution | Nationwide Distribution including states of AL, CA, FL, GA, KS, KY, LA, MN, NV, OH, OK, PA, SD, TN, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000956 | MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS Boston Scientific Scimed, Inc., Apr 21, 2000 |
| K964859 | SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS Scimed Life Systems, Inc., Feb 10, 1997 |
| K974559 | SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS Scimed Life Systems, Inc., Feb 23, 1998 |
| K992123 | SCIMED IMPULSE ANGIOGRAPHIC CATHETERS Boston Scientific Scimed, Inc., Aug 23, 1999 |