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Class 2 Device Recall DiamondTemp Unidrectional Ablation Catheter |
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Date Initiated by Firm |
February 22, 2021 |
Create Date |
March 29, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1317-2021 |
Recall Event ID |
87412 |
PMA Number |
P200028 |
Product Classification |
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
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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 |
Code Information |
All Lots |
Recalling Firm/ Manufacturer |
EPIX THERAPEUTICS, INC 945 Stewart Dr Ste 100 Sunnyvale CA 94085-3940
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For Additional Information Contact |
Kristy Simmons 408-470-4528
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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.
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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 |
100 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
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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.
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PMA Database |
PMAs with Product Code = OAE and Original Applicant = Medtronic Inc.
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