# FDA recall Z-0233-2022

> **Arrow International Inc** · Class I · device recall initiated 2021-09-20.

## Product

Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W  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.

## Distribution

Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: BE CA CL CZ DE ES FR IL IT KR PH SA TR TW UK

## Key facts

- **Recall number:** Z-0233-2022
- **Recalling firm:** Arrow International Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-09-20
- **Report date:** 2021-11-24
- **Termination date:** 2023-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Reading, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0233-2022

## Citation

> AI Analytics. FDA recall Z-0233-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0233-2022. Source: US FDA. Licensed CC0.

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