Recall Z-1000-2014 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified by the user. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures.
| 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
| K800178 | EXTRACORP.'S INTERSEPT CUS. TUBING PK. Extracorporeal Medical Specialities, Inc., Feb 21, 1980 |