Recall Z-1322-2021 ยท OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
EPIX THERAPEUTICS, INC
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013
| Date | Feb 22, 2021 |
| Status | Open, Classified |
| Reason | It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli. |
| Root cause | Under Investigation by firm |
| Action | On February 22, 2021, Medtronic issued a "Urgent Medical Device Correction" notification via regionally approved methods to consignees who have received affected product. In addition to informing consignees about the recall the firm asked consignees to take the following actions: 1. Review the corrected language applicable to IFU and label as provided in the Appendix below. Until the IFU is updated with the corrected information, the information provided in the Appendix should be used in combination with the existing labeling provided with the DiamondTemp" Catheters. 2. Please share this i |
| Quantity | 13 units |
| Distribution | Product was not distributed in the US. OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.