—#203600

Product

Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

FDA product code: DXE — Catheter, Embolectomy
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K892410
Affected lot / code info: UDI-DI: 00690103043532, Lot: 64936927

Why it was recalled

Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 1 Edwards Way, Irvine, California 92614-5688

Distribution

Distribution pattern: OUS: Singapore, Taiwan, Canada

Timeline

Recall initiated: 2023-09-07
Posted by FDA: 2023-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203600. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.