Edwards Lifesciences, LLC Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Brand
Edwards Lifesciences, LLC
Lot Codes / Batch Numbers
UDI-DI: 00690103043532, Lot: 64936927
Products Sold
UDI-DI: 00690103043532, Lot: 64936927
Edwards Lifesciences, LLC is recalling Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 due to Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Recommended Action
Per FDA guidance
On 9/7/23, correction notices were sent to customers informing them to take the following actions: 2) Return affected devices. 3) Forward notice to any of your customers who have purchased the impacted devices. 3) Complete and return the acknowledgement form.
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 noticePage updated: Jan 10, 2026