# FDA recall Z-0557-2022

> **Covidien Llc** · Class II · device recall initiated 2021-12-17.

## Product

Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular.  Product Numbers CH08-40-75GB and CH08-40-75US

## Reason for recall

The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector  sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks  associated with surgical intervention, or delay to treatment/therapy.

## Distribution

Worldwide distribution - US Nationwide and the countries of Germany, Israel, Italy, Portugal, Spain, Chile, Singapore, and China.

## Key facts

- **Recall number:** Z-0557-2022
- **Recalling firm:** Covidien Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-17
- **Report date:** 2022-02-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0557-2022

## Citation

> AI Analytics. FDA recall Z-0557-2022. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-0557-2022. Source: US FDA. Licensed CC0.

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