Arrow International Inc The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC, and PT-12709-WC) consists of a catheter with an expandable fragmentation basket attached to a through lumen torque cable and an outer catheter sheath. The catheter is used in conjunction with a low-speed, battery operated rotator unit to treat thrombosed hemodialysis grafts and AV fistulas. The macerating mechanism is done by 9 mm basket (made up of four stranded stainless steel wires) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC, and PT-12709-WC) consists of a catheter with an expandable fragmentation basket attached to a through lumen torque cable and an outer catheter sheath. The catheter is used in conjunction with a low-speed, battery operated rotator unit to treat thrombosed hemodialysis grafts and AV fistulas. The macerating mechanism is done by 9 mm basket (made up of four stranded stainless steel wires)
Brand
Arrow International Inc
Lot Codes / Batch Numbers
All units with Lot Numbers beginning with: MF311, MF312, MF401, MF402, MF403, MF404, MF405, MF406, MF407, MF408, MF409, MF410, MF411, MF412, MF501.
Products Sold
All units with Lot Numbers beginning with: MF311; MF312; MF401; MF402; MF403; MF404; MF405; MF406; MF407; MF408; MF409; MF410; MF411; MF412; MF501.
Arrow International Inc is recalling The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65 due to The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during use.
Recommended Action
Per FDA guidance
The firm began notification of consignees on 3/23/2005 via certified letter.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026