Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic… — Class I medical device recall Z-0232-2022

Terminated recall by Arrow International Inc, reported 2021-11-24, distributed nationwide. 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embo

Recall number	`Z-0232-2022`
Product type	Medical device
Classification	Class I
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Arrow International Inc, Reading, PA, United States
Recall initiated	2021-09-20
Classified	2021-11-18
Reported by FDA	2021-11-24
Terminated	2023-10-05
Distributed	Nationwide (US)
Countries outside the US	GB
Quantity	1,245 units
Reason classes	device malfunction
Lot numbers	`13F19K0369`, `13F20A0323`, `13F20B0139`, `13F20C0594`, `13F20F0083`, `13F20F0230`, `13F20F0577`, `13F20H0756`, `13F20K0849`, `13F20L0283`, `13F20M0182`, `13F21A0498`, `13F21B0158`, `13F21C0747`, `13F21E0555`

Product

Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts

Reason for recall

7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0232-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.