Arrow-Trerotola Percutaneous Thrombolytic Device inner lumen detachment and embolization risk
Arrow-Trerotola PTD catheters are being recalled because the inner lumen can detach from the device basket, causing embolization that requires additional intervention. 1,167 units are affected.
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 requires a minimum severity score of 4. The hazard—inner lumen detachment causing embolization—presents serious risk of patient harm requiring additional medical intervention, justifying a Severe rating.
Plain-English summary
Arrow International Inc is recalling the Arrow-Trerotola Percutaneous Thrombolytic Device (PTD), a 7FR catheter (Product Code PT-65709-W) used with the Arrow Rotator Drive Unit to mechanically remove blood clots from arteriovenous fistulae and synthetic dialysis grafts. Approximately 1,167 units are affected.
The inner lumen (orange component) can detach from the device basket during use. When detachment occurs, it results in embolization—displacement of blood clots or foreign material into the bloodstream—which requires additional medical intervention and delays treatment.
Affected lot numbers include 13F19M0129, 13F20B0053, 13F20C0595, 13F20F0231, 13F20G0361, 13F20K0632, 13F21A0353, 13F21C0748, 13F21D0721, 13F21E0823, and 13F21F1189. The devices were distributed worldwide to the United States and internationally to Belgium, Canada, Chile, Czech Republic, Germany, Spain, France, Israel, Italy, South Korea, the Philippines, Saudi Arabia, Turkey, Taiwan, and the United Kingdom.
The recalled product
- Product
- Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousf
- Manufacturer
- Arrow International Inc
- Hazard
- component-detachment
- embolization
Distribution
Distributed nationwide across the United States.
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