Recall Z-0995-2014 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-ve
| Date | Feb 20, 2014 (initiated Jan 30, 2014) |
| Status | Terminated |
| Reason | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. |
| Root cause | Under Investigation by firm |
| Action | The firm, Medtronic, sent an "Urgent Medical Device Recall" letter dated January, 2014 via UPS on January 30, 2014 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify and quarantine all listed product in your inventory; return all listed product to Medtronic and contact Customer Service at 800 854-3570 and reference RADAR #167826 to initiate a return and credit of product; complete and return the attached Customer Confirmation Certificate via fax to Medtronic at 651-367-0612 to the attention of Customer |
| Quantity | 19483 total (7669 US, 11814 OUS) |
| Distribution | Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paragu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043179 | SELECT 3D ARTERIAL CANNULA Medtronic Perfusion Systems, Feb 8, 2005 |