Recall Z-0588-2016 ยท DQY Catheter, Percutaneous
Boston Scientific Corporation
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead Delivery System is designed for venous use to aid in the selective placement of cardiac resynchronization therapy (CRT) implantable venous leads in the cardiac vasculature. The catheter shafts are compri
| Date | Jan 5, 2016 (initiated Nov 25, 2015) |
| Status | Terminated |
| Reason | Potential for separation of the proximal handle from the shaft. |
| Root cause | Process control |
| Action | Boston Scientific personnel began retrieving product from hospital shelves on November 25, 2015. The hospital was given a Medical Device Retrieval letter. The letter provided the reason for product retrieval, identified affected product, asked for product to be segregated to ensure that it will not be used, and to contact Boston Scientific for a return authorization number to ship product back to Boston Scientific. A Certificate of Removal was asked to be completed and emailed to BSCFieldActionCenter@bsci.com Questions can be addressed to Technical Services at 1-800-227-3422. |
| Quantity | 900 units |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Serbia, Singapore, Slovenia, Sp |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132914 | ACUITY PRO LEAD DELIVERY SYSTEM Boston Scientific, Apr 3, 2014 |