Use caution Medical device recall · FDA · Published December 17, 2021

Covidien Chameleon Catheter Recall: Difficulty Removing Balloon Protector Sleeve

Covidien recalls two types of Chameleon PTA Balloon Catheters due to difficulty removing the balloon protector sleeve, which may cause patient harm if the catheter is used after damage.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0557-2022Medical device Covidien ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmCovidien Llc15 Hampshire St · Mansfield, MA 02048-1113

✎ GovInfoNow plain-language explainer

Covidien is recalling two specific balloon catheters because users report needing excessive force to remove the balloon protector sleeve. If the sleeve is damaged during removal and the catheter is used in a medical procedure, it could cause serious patient harm like vessel perforation or embolism. Read more at govinfonow.com/recall/61420-covidien-chameleon-catheter-recall-difficulty-removing-balloon-protector-sleeve.

Source Summary by GovInfoNow · govinfonow.com/recall/61420-covidien-chameleon-catheter-recall-difficulty-removing-balloon-protector-sleeve · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0557-2022

Cite this page

“Covidien Chameleon Catheter Recall: Difficulty Removing Balloon Protector Sleeve.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61420-covidien-chameleon-catheter-recall-difficulty-removing-balloon-protector-sleeve. Based on FDA recall #Z-0557-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0557-2022%22&limit=1).

The FDA announced on 2021-12-17 that Covidien LLC is recalling Chameleon PTA Balloon Dilation Catheters due to potential patient harm if the balloon is damaged during use. The firm has received six complaint reports indicating difficulty removing the balloon protector sleeve.

How to tell if you have it

Brand: Covidien
Product: Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm
Product Numbers: CH08-40-75GB and CH08-40-75US
UDIs: 10884521812253, 07290016745047, 10884521812291
Distribution: Worldwide - US Nationwide and Germany, Israel, Italy, Portugal, Spain, Chile, Singapore, and China

The hazard

The firm has received six complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter. 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.

Context

GovInfoNow's records show Covidien LLC has 52 other recalls on record since 2017-08-07. Other recent recalls of similar products include Covidien EndoFLIP System: Catheters May Be Incorrectly Flagged as Expired (2026-05-13), Covidien Mon-a-Therm Temperature Probe Recall: Lack of FDA Clearance (2026-04-23), and Covidien Shiley Disposable Decannulation Plug Recall: Incorrect DEHP Labeling (2026-04-23). Other recent recalls of similar products include LeMaitre TufTex Catheter Recall: Risk of Balloon Failure During Use (2026-08-28) and Medline Urethral Catheter Tray Recall: Risk of Catheter Detachment (2026-05-04).

How to tell if you have this one

Check for product numbers CH08-40-75GB or CH08-40-75US on the catheter packaging. The recall includes specific batch numbers listed in the UDI and GTIN details provided in the official notice.

Brand
Covidien
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Numbers
Look for product numbers CH08-40-75GB or CH08-40-75US on the catheter packaging to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Germany, Israel, Italy, Portugal, Spain, Chile, Singapore, and China.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 54 days after the firm started it.

Dec 17, 2021Firm started the recall
Feb 3, 2022FDA classified it Class II
Feb 9, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61420-covidien-chameleon-catheter-recall-difficulty-removing-balloon-protector-sleeve">Covidien Chameleon Catheter Recall: Difficulty Removing Balloon Protector Sleeve (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0557-2022 (December 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0557-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.