Recall Z-0627-2022— TELEFLEX MEDICAL INC
Class I · Terminated
Class I FDA medical device recall by TELEFLEX MEDICAL INC, initiated 2022-01-11, terminated 2024-09-11. It names one FDA 510(k) clearance: K011056. Product: Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.. Reason: The firm received reports indicating PTD tip separation during use..
- Recalling firm
- TELEFLEX MEDICAL INC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2022-01-11
- Terminated
- 2024-09-11
- Firm location
- Morrisville, NC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
Reason for recall
The firm received reports indicating PTD tip separation during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.