Chameleon recallZ-0557-2022 · Covidien Llc · initiated Dec 17, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
On December 17, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Patient recommendation: Continue to monitor patients according to your hospital's patient management process. Required Actions: 1. Please immediately quarantine and discontinue use of the affected item code. 2. Please return affected product as indicated below. All products from the affected item code and lots listed below must be returned. 3. If you have distributed the products listed above, please promptly forward the information from this letter to those recipients. 4. Please complete the Recalled Product Return Form even if you do not have inventory. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Recall details
- Recall number
- Z-0557-2022
- Status
- Open, Classified
- Initiated by the company
- Dec 17, 2021
- Posted by the FDA
- Feb 3, 2022
- Recalling firm
- Covidien Llc
- Quantity
- 1,994 devices
- Product code
- LIT
- FDA submissions
- K163231
- Distribution
- Worldwide distribution - US Nationwide and the countries of Germany, Israel, Italy, Portugal, Spain, Chile, Singapore, and China.
Product description
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
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
UDI: 10884521812253, 07290016745047, 10884521812291 For CFN CH08-40-75US: GTIN Batch 07290016745047 21904374 07290016745047 21904432 07290016745047 22000673 07290016745047 22000709 07290016745047 22000817 07290016745047 22000880 07290016745047 22001030 07290016745047 22001061 07290016745047 22001191 07290016745047 22001310 07290016745047 22001417 07290016745047 22001448 07290016745047 22001728 07290016745047 22002086 07290016745047 22002088 10884521812253 22002498 07290016745047 22002583 10884521812253 22002603 07290016745047 22003037 07290016745047 22100003 07290016745047 22100321 07290016745047 22100322 07290016745047 22101089 07290016745047 22101090 10884521812291 22102189
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Chameleon CH08-40-75USMozarc Medical US LLC · Catheter, continuous flush2 recalls4 reports
- Chameleon 8x40Av Medical Technologies Ltd · Catheter, Angioplasty, Peripheral, Transluminal1 recall15 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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