# FDA recall Z-0629-2022

> **TELEFLEX MEDICAL INC** · Class I · device recall initiated 2022-01-11.

## Product

Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit)     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 for recall

The firm received reports indicating PTD tip separation during use.

## Distribution

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.

## Key facts

- **Recall number:** Z-0629-2022
- **Recalling firm:** TELEFLEX MEDICAL INC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-01-11
- **Report date:** 2022-02-23
- **Termination date:** 2024-09-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0629-2022

## Citation

> AI Analytics. FDA recall Z-0629-2022. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0629-2022. Source: US FDA. Licensed CC0.

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