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-0624-2022
- 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-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS 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: 13F20A0323 / (01)108019022121292 (17)211231 (10)13F20A0323, Components: Code PT-65709-C, Lot number 13C19M0499; Code PT-65709-HFS, Lot number 14C19J0342; Code PT-03009, Lot number 13C19J1873; Code PT-03009, Lot number 13C19L0622; Code PT-03009, Lot number 13C19J0572; Code PT-03009, Lot number 13C19K0832; Lot Number / UDI: 13F20B0139 / (01)10801902121292 (17)220131 (10)13F20B0139, Components: Code PT-65709-C, Lot number 13C20A0970; Code PT-65709-HFS, Lot number 14C20A0611; Code PT-65709-HFS, Lot number 14C19G0671; Code PT-03009, Lot number 13C19L0622; Lot Number / UDI: 13F20C0594 / (01)10801902121292 (17)220331 (10)13F20C0594, Components: Code PT-65709-C, Lot number 13C20C2082; Code PT-65709-HFS, Lot number 14C20A0611; Code PT-65709-HFS, Lot number 14C19J0342; Code PT-03009, Lot number 13C20B1435; Lot Number / UDI: 13F20F008 3/ (01)10801902121292 (17)220531 (10)13F20F0083, Components: Code PT-65709-C, Lot number 13C20F0572; Code PT-65709-HFS, Lot number 14C20D1060; Code PT-65709-HFS, Lot number 14C20A0611; Code PT-03009, Lot number 13C20C1558; Code PT-03009, Lot number 13C20B1435; Lot Number / UDI: 13F20F0230 / (01)10801902121292 (17)220531 (10)13F20F0230, Components: Code PT-65709-C, Lot number 13C20F1139; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-65709-HFS, Lot number 14C20D1060; Code PT-03009, Lot number 13C20F0570; Lot Number / UDI: 13F20F0577 / (01)10801902121292 (17)220630 (10)13F20F0577, Components: Code PT-65709-C, Lot number 13C20F2175; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-03009, Lot number 13C20F1138; Code PT-03009, Lot number 13C20F0570; Lot Number / UDI: 13F20H0756 / (01)10801902121292 (17)220831 (10)13F20H0756, Components: Code PT-65709-C, Lot number 13C20G1976; Code PT-65709-HFS, Lot number 14C20F0274; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-03009, Lot number 13C20H0604; Code PT-03009, Lot number 13C20G1198; Lot Number / UDI: 13F20K0849 / (01)10801902121292 (17)221031 (10)13F20K0849, Components: Code PT-65709-C, Lot number 13C20H1675; Code PT-65709-C, Lot number 13C20G1976; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-65709-HFS, Lot number 14C20F0274; Code PT-03009, Lot number 13C20H0604; Lot Number / UDI: 13F20L0283 / (01)10801902121292 (17)221031 (10)13F20L0283, Components: Code PT-65709-C, Lot number 13C20H1675; Code PT-65709-C, Lot number 13C20J2689; Code PT-65709-HFS, Lot number 14C20J1446; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-03009, Lot number 13C20L0872; Lot Number / UDI: 13F20M0182 / (01)10801902121292 (17)221231 (10)13F20M0182, Components: Code PT-65709-C, Lot number 13C20J2689; Code PT-65709-C, Lot number 13C20H1675; Code PT-65709-HFS, Lot number 14C20L0665; Code PT-65709-HFS, Lot number 14C20J1446; Code PT-03009, Lot number 13C20L0871; Lot Number / UDI: 13F21A0498 / (01)10801902121292 (17)221231 (10)13F21A0498, Components: Code PT-65709-C, Lot number 13C20M0639; Code PT-65709-HFS, Lot number 14C20J1446; Code PT-03009, Lot number 13C21A0855; Lot Number / UDI: 13F21B0158 / (01)10801902121292 (17)230131 (10)13F21B0158, Components: Code PT-65709-C, Lot number 13C21A1348; Code PT-65709-HFS, Lot number 14C20M0932; Code PT-65709-HFS, Lot number 14C20L0665; Code PT-65709-HFS, Lot number 14C20J1446; Code PT-03009, Lot number 13C21A0855; Lot Number / UDI: 13F21C0747 / (01)10801902121292 (17)230331 (10)13F21C0747, Components: Code PT-65709-C, Lot number 13C21C0326; Code PT-65709-C, Lot number 13C21A1348; Code PT-65709-HFS, Lot number 14C20L0665; Code PT-65709-HFS, Lot number 14C20M0932; Code PT-03009, Lot number 13C21B1533; Lot Number / UDI: 13F21E0555 / (01)108019021212292 (17)230430 (10)13F21E0555, Components: Code PT-65709-C, Lot number 13C21E0328; Code PT-65709-C, Lot number 13C21D0717; Code PT-65709-C, Lot number 13C21C2412; Code PT-65709-HFS, Lot number 14C21C0895; Code PT-65709-HFS, Lot number 14C20M0932; Code PT-03009, Lot number 13C21C2413; Code PT-03009, Lot number 13C21C2397
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 |