Fogarty Thru-Lumen Embolectomy Catheter Recalled for Delayed Balloon Deflation
Edwards Lifesciences is recalling Fogarty Thru-Lumen Embolectomy Catheters that may deflate more slowly than normal, potentially affecting device function during vascular procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device with a documented functional defect that could impair performance during invasive procedures. Although no injuries or hospitalizations have been reported, the slower-than-normal balloon deflation poses a potential risk during medical use. The FDA classification is Class II, which does not meet the threshold for Severe (which requires hospitalization reports).
Plain-English summary
Edwards Lifesciences is recalling the Fogarty Thru-Lumen Embolectomy Catheter, model REF: 12TLW805F35, due to a manufacturing defect that may cause slower-than-normal balloon deflation.
Affected catheters may experience balloon deflation times greater than 15 seconds, which is slower than the expected performance. This functional defect could impair the catheter's intended performance during embolectomy procedures and potentially complicate medical treatment.
The recall affects 185 units distributed outside the United States, specifically to Singapore, Taiwan, and Canada (Lot 64936927). Healthcare facilities that received these devices should verify whether they have stock of the affected lot and discontinue use immediately.
Institutions should contact Edwards Lifesciences for guidance on device replacement or return. Healthcare providers should report any adverse events involving this device to the FDA's MedWatch program.
The recalled product
- Product
- Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
- Manufacturer
- Edwards Lifesciences, LLC
- Affected units
- 185
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00690103043532
- Lot: 64936927
Distribution
Distribution scope not specified by the agency.
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