FDA Device recall Z-0627-2022
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Per…
- FDA Device
- Class I
- terminated
- Published 2022-02-23
On 2022-02-23 the FDA classified a Class I recall of Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Per… by Teleflex Medical, citing the firm received reports indicating PTD tip separation during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0627-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-01-11 |
| Published | 2022-02-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Teleflex Medical |
| Distribution | US |
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.
Identifiers
| code_info | Lot Number / UDI: 13F20A0209 / (01)10801902121261(17)211231(10)13F20A0209, Components: Code PT-45509-S6, Lot number 14…Lot Number / UDI: 13F20A0209 / (01)10801902121261(17)211231(10)13F20A0209, Components: Code PT-45509-S6, Lot number 14C19F1336; Code PT-45509-S6, Lot number 14C19J0340; Code PT-45509-T, Lot number 13C19L1173; Code PT-45509-T, Lot number 13C19M0193; Lot Number / UDI: 13F20B0054 / (01)10801902121261(17)220131(10)13F20B0054, Components: Code PT-45509-S6, Lot number 14C19F1336; Code PT-45509-S6, Lot number 14C19J0340; Code PT-45509-S6, Lot number 14C20A0602; Code PT-45509-T, Lot number 13C19L1173; Code PT-45509-T, Lot number 13C20A1583; Code PT-45509-T, Lot number 13C19M0193; Lot Number / UDI: 13F20B0527 / (01)10801902121261(17)220228(10)13F20B0527, Components: Code PT-45509-T, Lot number 13C20A2409; Code PT-45509-S6, Lot number 14C20A0602; Lot Number / UDI: 13F20C0427 / (01)10801902121261(17)220228(10)13F20C0427, Components: Code PT-45509-S6, Lot number 14C20A0602; Code PT-45509-T, Lot number 13C20A2409; Code PT-45509-T, Lot number 13C20A2409; Code PT-45509-T, Lot number 13C20C0 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0627-2022%22
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