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# Arrow Thrombolytic Device Recall Class 1
- URL: https://www.fdaweb.com/arrow-thrombolytic-device-recall-class-1/
- Published: 2022-02-24T12:00:00.000Z
- Updated: 2026-09-14T17:34:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151234

FDA says the 12/22/21 Arrow International recall of its Arrow-Trerotola percutaneous thrombolytic device is Class 1\. An agency [notice](https://www.fda.gov/medical-devices/medical-device-recalls/arrow-international-llc-subsidiary-teleflex-inc-recalls-arrow-trerotola-percutaneous-thrombolytic?ref=fdaweb.com) says the company recalled 24,895 units manufactured between 1/1/20 and 12/31/21 and distributed between 2/1/20 and 12/31/21.

The device consists of a catheter with an expandable basket attached to a drive cable. The catheter is said to be used with a low-speed, battery-operated rotator unit to remove blood clots in native arterio-venous fistulae and synthetic dialysis grafts.

Arrow recalled the devices due to a risk of tip damage during use, which could result in tip detachment from the basket. FDA says that as of 12/2021, 35 complaints reporting tip separation had been received, with 14 reporting injuries and nine involving the use of a stent to manage the separated tip. No deaths had been reported as of 12/2021.