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U.S. Department of Health and Human Services

Class 2 Device Recall SwanGanz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter

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  Class 2 Device Recall SwanGanz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter see related information
Date Initiated by Firm February 14, 2023
Date Posted April 12, 2023
Recall Status1 Open3, Classified
Recall Number Z-1379-2023
Recall Event ID 91868
Product Classification Catheter, flow directed - Product Code DYG
Product Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)
Code Information Primary DI Number: 00690103146554/ Lot: 64191420 64228620 64229652 64238028 64238630 64243142 64243143 64260684 64260685 64262168 64264946 64278346 64289390 64289391 64289408 64304361 64304362 64304363 64314476 64314477 64314479 64320628 64325327 64328112 64328113 64328114 64328115 64337979 64337980 64337981 64345011 64345012 64355442 64362238 64362239 64362240 64362241 64362242 64373343 64373344 64373345 64381703 64383275 64383276 64383277 64385609 64385610 64385611 64385612 64385613 64398982 64398983 64398984 64410910 64410911 64410912 64410913 64410914 64423626 64423627 64423628 64423629 64423630 64430338 64430339 64430340 64446892 64446893 64446894 64446895 64458777 64458778 64458779 64462548 64462549 64470780 64470781 64470782 64470783 64478098 64478099 64483100 64483101 64483102 64483103 64483104 64496490 64496491 64514042 64540629 64540630 64540631 64552372 64577637 64578749 64578750 64584948 64584949 64584950 64584951 64584952 64603534 64609691 64613340 64617864 64623071 64636398 64664097 64664390 64742870 64746321 64746322 64762706 64769085
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact linnette_torres@edwards.com
949-756-4582
Manufacturer Reason
for Recall		 There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
FDA Determined
Cause 2		 Packaging process control
Action On March 10, 2023, Edwards issued a "Urgent Medical Device Correction" notification to affected consignees. In addition to informing consignees about the correction, Edwards ask consignees to take the following actions: Actions to be taken by customer 1. Review the customer letter for advice on action to be taken. 2. Please follow the instructions included in the enclosed acknowledgement form to complete the acknowledgement process. 3. Distribute this notice within your organization or to any organization where the potentially impacted product has been transferred. 4. Please post a copy of this notice near and/or with affected devices. 5. Verify your inventory on the attached acknowledgement form. 6. Contact Edwards Customer Service at 1-888-352-0904 for a Return Goods Authorization (RGA) if you would like an exchange of your device or to request a biokit if returning used devices. Actions to be taken by distributors: 1. Please review this letter and complete the acknowledgement form. Return the acknowledgement form to US.FCA@edwards.com within 15 days of receipt of this notification. Please forward this customer communication to any of your customers who have purchased the impacted Edwards product. If you still have product within your control, please do not distribute impacted product to any customers. You can call Edwards Customer Service for instructions for handling product still within your control. 2. Alternatively, you can provide Edwards with a list of your customers who have purchased the impacted product from you and Edwards will communicate directly with your customers to facilitate the correction and acknowledgement process. Please forward your customer list to US.FCA@edwards.com. If you have any questions, please contact Edwards Customer Service at: 1-888-352-0904. Adverse Event Reporting in the US: 1. Please contact the FDA s MedWatch Adverse Event reporting program either online, by regular mail, or by fax: Complete and submit the report Onl
Quantity in Commerce 59,094 units
Distribution US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV WY OUS: None
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.
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