Recall Z-1159-2007 ยท DQO Catheter, Intravascular, Diagnostic
Boston Scientific Corporation
Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391022, (5-Pack Carton Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391021, (Single Pack Carton/Pouch Label), Angiographic Catheters. Made in Mexico Parque Industrial La Me
| Date | Aug 9, 2007 (initiated Jun 4, 2007) |
| Status | Terminated |
| Reason | Labels on the carton from two batches/lots of Impulse Angiographic Catheters may indicate a different curve style than the device that is actually in the carton. |
| Root cause | Process control |
| Action | Sales Force were contacted of the product and problem via voice mail and a memo dated June 4, 2007. Customers were contacted via a letter on June 4, 2007. |
| Quantity | 235 |
| Distribution | Worldwide, including USA, Austria, Australia, Belgium, Chile, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Panama, Poland, Sweden, Thailand, and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964859 | SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS Scimed Life Systems, Inc., Feb 10, 1997 |