EPIX THERAPEUTICS, INC EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198
Brand
EPIX THERAPEUTICS, INC
Lot Codes / Batch Numbers
All Lots
Products Sold
All Lots
EPIX THERAPEUTICS, INC is recalling EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm due to 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 co. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026