FOGARTY recallZ-0238-2024 · Edwards Lifesciences, LLC · initiated Sep 7, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Edwards Lifesciences, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0238-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 7, 2023
- Posted by the FDA
- Nov 6, 2023
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 185
- Product code
- DXE
- FDA submissions
- K892410
- Distribution
- OUS: Singapore, Taiwan, Canada
Product description
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Code information (models, lots, serial numbers)
UDI-DI: 00690103043532, Lot: 64936927
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- FOGARTY 12TLW805F35Edwards Lifesciences LLC · CATHETER, EMBOLECTOMY1 recall44 reports
Product lines
Other devices under the same FDA submission
8 devices cleared under K892410 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- FOGARTY 12TLW405F35Edwards Lifesciences LLC · CATHETER, EMBOLECTOMY25 reports
- FOGARTY 12TLW804FEdwards Lifesciences LLC · CATHETER, EMBOLECTOMY22 reports
- FOGARTY 12TLW803FEdwards Lifesciences LLC · CATHETER, EMBOLECTOMY19 reports
- FOGARTY 12TLW806FEdwards Lifesciences LLC · CATHETER, EMBOLECTOMY5 reports
- FOGARTY 12TLW403FEdwards Lifesciences LLC · CATHETER, EMBOLECTOMY4 reports
- FOGARTY 12TLW404FEdwards Lifesciences LLC · CATHETER, EMBOLECTOMY3 reports
- FOGARTY 12TLW807FEdwards Lifesciences LLC · CATHETER, EMBOLECTOMY3 reports
- FOGARTY 12TLW1203FEdwards Lifesciences LLC · CATHETER, EMBOLECTOMY1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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