Arrow-Trerotola Percutaneous Thrombolytic Device Catheter Lumen Detachment Recall
Arrow International is recalling Arrow-Trerotola Percutaneous Thrombolytic Device catheters because the inner lumen can detach from the device basket, causing embolization requiring additional intervention and delaying dialysis therapy. Approximately 1,245 units are affected worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall. The defect presents risk of device component detachment causing embolization and requiring additional intervention to retrieve, with potential to delay critical dialysis therapy. No deaths or serious injuries are reported in the source material.
Plain-English summary
Arrow International is recalling Arrow-Trerotola Over-The-Wire Percutaneous Thrombolytic Device (PTD) catheters (7FR, Product Code PT-65709-HFWC) due to a defect where the inner lumen (orange) can detach from the device basket. When detachment occurs, it can result in embolization that requires retrieval through additional intervention, delaying necessary dialysis therapy.
These catheters are used in conjunction with the Arrow Rotator Drive Unit for mechanical declotting of native arterio-venous fistulae and synthetic dialysis grafts. Approximately 1,245 units have been distributed worldwide to healthcare facilities in the United States and internationally.
The recalled lot numbers include: 13F19K0369, 13F20A0323, 13F20B0139, 13F20C0594, 13F20F0083, 13F20F0230, 13F20F0577, 13F20H0756, 13F20K0849, 13F20L0283, 13F20M0182, 13F21A0498, 13F21B0158, 13F21C0747, and 13F21E0555. International distribution includes Belgium, Canada, Chile, Czech Republic, Germany, Spain, France, Israel, Italy, South Korea, 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-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native…
- Manufacturer
- Arrow International Inc
- Affected units
- 1,245
Distribution
Part of a larger recall action
This product is one of 4 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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