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U.S. Department of Health and Human Services

Class 2 Device Recall DiamonTemp Bidrectional Ablation Catheter

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  Class 2 Device Recall DiamonTemp Bidrectional Ablation Catheter see related information
Date Initiated by Firm February 22, 2021
Create Date March 29, 2021
Recall Status1 Open3, Classified
Recall Number Z-1320-2021
Recall Event ID 87412
PMA Number P200028 
Product Classification Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
Product EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303
Code Information All Lots
Recalling Firm/
Manufacturer		 EPIX THERAPEUTICS, INC
945 Stewart Dr Ste 100
Sunnyvale CA 94085-3940
For Additional Information Contact Kristy Simmons
408-470-4528
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 18 units
Distribution Product was not distributed in the US. OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = OAE and Original Applicant = Medtronic Inc.
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