Arrow-Trerotola Percutaneous Thrombolytic Device: Inner Lumen Detachment Risk
Arrow International is recalling 1918 units of the Arrow-Trerotola Percutaneous Thrombolytic Device due to inner lumen detachment that can cause embolization, requiring emergency retrieval and delaying treatment.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity of 4. The hazard involves device component detachment causing embolization that requires emergency surgical intervention, representing significant clinical risk despite no specific injuries being reported in the source.
Plain-English summary
Arrow International Inc is recalling 1918 units of the Arrow-Trerotola Over-The-Wire Percutaneous Thrombolytic Device (7FR, Product Code: PT-65709-WC). The device is used to mechanically remove blood clots from native arterio-venous fistulae and synthetic dialysis grafts.
The inner lumen (orange component) of the device basket can detach during use. When detachment occurs, it can lead to embolization—the formation or migration of blood clots within the patient's blood vessels. This condition requires additional emergency medical intervention to retrieve the clot and results in delay of the intended therapy.
The recalled units were distributed worldwide, including throughout the United States and to Belgium, Canada, Chile, Czech Republic, Germany, Spain, France, Israel, Italy, South Korea, Philippines, Saudi Arabia, Turkey, Taiwan, and the United Kingdom. Affected lot numbers are listed in the FDA notice.
Facilities and healthcare providers should immediately cease use of the affected lots and contact Arrow International Inc for instructions regarding product return or replacement.
The recalled product
- Product
- Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous
- Manufacturer
- Arrow International Inc
- Hazard
- device-failure
- embolization
- delayed-treatment
Distribution
Distributed nationwide across the United States.
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