Teleflex Incorporated (NYSE: 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.
