Teleflex Recalls Percutaneous Thrombolytic Device Kits

Teleflex Incorporated TFX announced a worldwide recall of Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR. 

• The FDA classified the recall as a Class I recall, wherein using or exposure to a defective product will cause serious adverse health consequences or death.
• In conjunction with the Arrow Rotator Drive Unit, the Arrow-Trerotola PTD Catheter permits mechanical declotting of native arteriovenous (AV) fistulae and synthetic dialysis grafts.
• Teleflex initiated the recall in September due to reports indicating that the PTD's Inner lumen detached from the device's basket. 
• If the inner lumen detaches from the basket, health consequences depend upon whether and where the fractured tip component embolizes. 
• In most cases, the embolization is local to the treatment target site, allowing retrieval with additional intervention and consequent therapy delay. 
• In some cases, the embolization could be central or peripheral and result in or threaten to cause local ischemia. 
• As of November 2021, a total of seven customer complaints have been received for this issue. 
• In one complaint, a snare was used by the clinician to retrieve the separate lumen from the patient. No long-term patient complications have been reported.
• Price Action: TFX shares closed down by 3.97% at $305.15 on Friday.