Edwards Lifesciences Recalls ThruPort Knot Pusher Due to Suture Fraying Risk
Edwards Lifesciences is recalling 759 ThruPort Knot Pusher units because the device's tip design may cause suture fraying or splitting, potentially compromising suture knot integrity during cardiac surgery.
What this means for you
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: The recall involves a high-risk medical device used in cardiac surgery where a defect could compromise suture integrity, representing a risk of harm even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Edwards Lifesciences, LLC is recalling 759 units of the ThruPort Knot Pusher (Model KP1) and the ThruPort Valve Placement Pack (Model VPP). The device is a sterile, disposable plastic rod used to advance extracorporeal suture knots during minimally invasive cardiac surgery. The affected units were distributed nationwide in the United States and internationally to Canada, Japan, and Europe.
The recall was initiated because the configuration of the slot at the tip of the knot pusher may inhibit the intended ease of use. This design issue could lead to the fraying or splitting of the suture, which could compromise the integrity of the suture knot.
The recall includes specific lot numbers for Model KP1 (59964698, 59967596, 59984375, 60016312, 60045801, 60045802, 60059982, 60066591, 60089865) and Model VPP (60022521, 60022522, 60064112). Healthcare providers and facilities should stop using the affected devices and contact Edwards Lifesciences for instructions on return or replacement.
The recalled product
- Product
- ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal
- Manufacturer
- Edwards Lifesciences, LLC
- Affected units
- 759
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 (11)
- Model: KP1 - Lot No: 59964698
- 59967596
- 59984375
- 60016312
- 60045801
- 60045802
- 60059982
- 60066591
- 60089865 Model VPP Lot No: 60022521
- 60022522
- 60064112
Distribution
Distributed nationwide across the United States.
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