Arrow International has recalled its Arrow-Trerotola over-the-wire 7Fr percutaneous thrombolytic device (PTD) kits, which are used to remove clots in adult patients who have arteriovenous fistulas (AVFs) and synthetic dialysis grafts.
The recall has been attributed to the risk of the orange inner lumen of the Arrow-Trerotola PTD catheter’s tip component separating from the device’s self-expanding basket. A statement from the US Food and Drug Administration (FDA) adds that, if this occurs, the lumen may fracture and detach, and block the blood vessel(s) it is being used in.
Resulting health consequences depend upon where the fractured tip component embolises, the FDA statement continues. If the embolisation is local to the treatment target site, retrieval may be attempted, requiring an additional intervention and consequent delay of therapy. In some cases, the embolisation could be central, or possibly even to the heart or pulmonary arteries. This may lead to serious adverse events, such as vessel damage, need for additional medical procedures, or possibly death, the statement adds.
The FDA has identified this as a Class I recall—the most serious type of recall—meaning use of these devices may cause serious injuries or death. To date, there have been seven complaints and no injuries or deaths reported for the Arrow-Trerotola PTD kits.
Arrow, which is a subsidiary of Teleflex, has recalled 3,241 of these devices in the USA following initiation of the recall in August 2021.
More information for healthcare providers or patients who may be affected by the recall can be found here.