Class I Recall of Edwards Lifesciences Recalls Swan-Ganz Thermodilution Catheter
Edwards Lifesciences is recalling 131F7, 131F7J, 131F7P, 131VF7P, 151F7 Swan-Ganz Thermodilution Catheters manufactured December 26, 2017, to April 19, 2018 due, to incorrect assembly and reversal of the lumens. If the lumens are reversed the clinician may note inaccurate pulmonary artery and central venous pressure values and waveforms. This may result in unintended treatment, which may result in adverse health consequences.
The inaccurate waveforms and pressure values may also misguide a physician during placement of the catheter, increasing the risk of blood vessel perforation. This exposes the patient to a reasonable likelihood of a serious adverse health consequence or death.
Recalled Product Details:
- Edwards Lifesciences Swan-Ganz Thermodilution Catheter
- Model Numbers: 131F7, 131F7J, 131F7P, 131VF7P, 151F7
- Lot Numbers: 61321177, 61176373, 61227528, 61321254, 61176369, 61176314, 61176370, 61176367, 61176374, 61321241, 61311580
- Manufacturing Dates: December 26, 2017, to April 19, 2018
- Distribution Dates: January 20, 2018, to August 20, 2018
- Devices Recalled in the U.S.: 1,426
On December 12, 2018, Edwards Lifesciences sent affected customers an “Urgent Recall Notification Letter” informing of affected model/lot numbers. The notice requested that customers return any unused units that are currently in their inventory with the affected model and lot numbers. Once returned, replacement product will be shipped to customers at no charge. Edwards Lifesciences prepopulated a “Customer Acknowledgement” form, attached to the notification, with the affected lots and requested that customers follow the instructions on the form to complete the recall process.
Customers with questions may contact Edward Lifesciences Technical Support Department at 1-(800)-822-9837 option 1.
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