Terumo Cardiovascular Corporation
Medical device manufacturer in Elkton, MD.
0510(k) clearances
0PMA approvals
11recalls
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2950-2011 | CAPIOX Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC…Reservoir blood bag used in cardiovascular procedures may leak. | 07/21/2011Terminated |
| Z-0842-2012 | Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 .…Complaints were received of expired X-coated Capiox SX18 Hollow Fiber oxygenators. | 06/28/2010Terminated |
| Z-2617-2010 | Cardiovascular Procedure Kit X-Coated H/L pack with Cardioplegia, Item # 70067-03Medical device vent port may be occluded and prevent delivery of priming fluid. | 06/08/2010Terminated |
| Z-2616-2010 | Cardiovascular Procedure Kit Custom 4:1 Myocardial Set, (MP4 w/ Coil Component…Medical device vent port may be occluded and prevent delivery of priming fluid. | 06/08/2010Terminated |
| Z-2615-2010 | Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part…Medical device vent port may be occluded and prevent delivery of priming fluid. | 06/08/2010Terminated |
| Z-2614-2010 | Cardiovascular Procedure Kit X-Coated Pump and Table Pack, Item #71552Medical device vent port may be occluded and prevent delivery of priming fluid. | 06/08/2010Terminated |
| Z-2613-2010 | Sarns Cardioplegia Set CPLG BLD MP4 4:1 No recirculation, Item # 16010Medical device vent port may be occluded and prevent delivery of priming fluid. | 06/08/2010Terminated |
| Z-2612-2010 | Sarns Cardioplegia Set with w/ PVC Coil from MP4, Item # 15501Medical device vent port may be occluded and prevent delivery of priming fluid. | 06/08/2010Terminated |
| Z-2611-2010 | Sarns Cardioplegia Set with Conducer Heat Exchanger Cplg/MP4 4:1, Item # 165720Medical device vent port may be occluded and prevent delivery of priming fluid. | 06/08/2010Terminated |
| Z-2610-2010 | Sarns Cardioplegia Set Conducer Heat Exchanger Cplg/MP4 4:1 Bridge, Item# 6375Medical device vent port may be occluded and prevent delivery of priming fluid. | 06/08/2010Terminated |
| Z-2606-2010 | Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular…Medical device component may malfunction and require user intervention during surgical bypass procedures. | 03/15/2010Terminated |