# FDA recall Z-1756-2019

> **Cook Inc.** · Class I · device recall initiated 2019-05-24.

## Product

Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248    Product Usage:  The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature.

## Reason for recall

Multiple complaints were received for balloons bursting below the rated burst pressure.  Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and balloon fragmentation in the patient.

## Distribution

Worldwide Distribution - US Nationwide  The affected product was distributed to the following states: FL, OH, WA.    The products were distributed to the following foreign countries:  Belgium, Denmark, Finland, Germany, Italy, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-1756-2019
- **Recalling firm:** Cook Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-24
- **Report date:** 2019-06-26
- **Termination date:** 2019-10-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1756-2019

## Citation

> AI Analytics. FDA recall Z-1756-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1756-2019. Source: US FDA. Licensed CC0.

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