CLASS I Device recall · Reported 23 Feb 2022 · FDA Enforcement Report
Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical
Teleflex Medical is recalling Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, distributed nationwide in the US. The recall was initiated on 11 Jan 2022 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0623-2022
- FDA event ID
- 89390
- Recalling firm
- Teleflex Medical, Morrisville, NC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 11 Jan 2022
- FDA classified
- 15 Feb 2022
- Reported
- 23 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 11 Jan 2022 | Recall initiated by company | |
| 15 Feb 2022 | Classified by FDA | +35 days |
| 23 Feb 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm received reports indicating PTD tip separation during use.
Product as listed by the FDA
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-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.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
The firm received reports indicating PTD tip separation during use.
Which lots are affected?
Lot Number / UDI: 13F19K0564 / (01)20801902156758 (17)210930 (10)13F19K0564, Components: Code PT-12709-CA, Lot number 13C19K2024; Code PT-65709-HS, Lot number 14C19K1035; Code PT-03009, Lot number 13C19J1873; Lot Number / UDI: 13F20C0094 / (01)10801902121254 (17)220228 (10)13F20C0094, Components: Code PT-12709-C, Lot number 13C20C0498; Code PT-65709-HS, Lot number 14C19K1035; Code PT-03009, Lot number 13C19L0622; Code PT-03009, Lot number 13C19M0278; Code PT-03009, Lot number 13C19J1873; Lot Number / UDI: 13F20G0284 / (01)10801902121254 (17)220630 (10)13F20G0284, Components: Code PT-12709-C, Lot number 13C20G0230; Code PT-65709-HS, Lot number 14C20D1061; Code PT-03009, Lot number 13C20G0238; Code PT-03009, Lot number 13C20F2585; Lot Number / UDI: 13F20L0282 / (01)10801902121254 (17)221031 (10)13F20L0282, Components: Code PT-12709-C, Lot number 13C20J0307; Code PT-65709-HS, Lot number 14C20H0384; Code PT-03009, Lot number 13C20L0872; Lot Number / UDI 13F21A0497 / (01)10801902121254 (17)221231 (10)13F21A0497, Components: Code PT-12709-C, Lot number 13C20J0307; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C20M0144; Lot Number / UDI: 13F21A0718 / (01)10801902121254 (17)230131 (10)13F21A0718, Components: Code PT-12709-C, Lot number 13C21A1963; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C21A0855; Code PT-03009, Lot number 13C20M0144; Lot Number / UDI: 13X21E0008 / (01)10801902121254 (17)230630 (10)13F21F1187, Components: Code PT-12709-C, Lot number 13C21C1690; Code PT-65709-HS, Lot number 14C21D0635; Code PT-65709-HS, Lot number 14C21C0476; Code PT-03009, Lot number 13C21C2413; Lot Number / UDI: 13F21F1187 / (01)10801902121254 (17)230531 (10)13X21E0008, Components: Code PT-12709-C, Lot number 13X21E0009; Code PT-65709-HS, Lot number 14X21D0002; Code PT-03009, Lot number 13X21E0007
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 89390This product is part of a recall event; the main page for the event is Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide | |
| CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide | |
| CLASS I | Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device recalled | Teleflex Medical | Other | Nationwide | |
| CLASS I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled | Teleflex Medical | Other | Nationwide | |
| CLASS I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled | Teleflex Medical | Other | Nationwide | |
| CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
More recalls from Teleflex Medical
All 235| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS II | Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile recalled | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled | Teleflex Medical | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |