Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; C

FDA device recall Z-0557-2022 · posted 2022-02-03 · Open, Classified

Recall details

Recalling firm

Covidien Llc

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LIT

Quantity affected

1,994 devices

Distribution

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

Date initiated

2021-12-17

Date posted

2022-02-03

Location

Mansfield, MA

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