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
- Company
- Epix Therapeutics, Inc
- Recall Initiated
- February 22, 2021
- Recall Number
- Z-1322-2021
- Quantity
- 13 units
- Firm Location
- Sunnyvale, CA
Reason for Recall
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.
Distribution
Product was not distributed in the US. OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada
Lot / Code Info
All Lots
Root Cause
Under Investigation by firm
Action Taken
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 information with healthcare professionals in your facility that use DiamondTemp" Catheters. Also share this information with any other organization where these devices may have been transferred. 3. Please maintain a copy of this notice in your records. We are committed to patient safety and welcome any questions you may have regarding this communication. Please contact your Medtronic representative with questions.