Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C 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.
Reported: February 23, 2022 Initiated: January 11, 2022 #Z-0625-2022
Product Description
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C 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.
Details
- Recalling Firm
- TELEFLEX MEDICAL INC
- Units Affected
- 1265 units
- Distribution
- Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.
- Location
- Morrisville, NC
Frequently Asked Questions
What product was recalled? ▼
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C 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.. Recalled by TELEFLEX MEDICAL INC. Units affected: 1265 units.
Why was this product recalled? ▼
The firm received reports indicating PTD tip separation during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 23, 2022. Severity: Critical. Recall number: Z-0625-2022.
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