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Covidien Llc recalls Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; C
Recalled February 9, 2022 · FDA recall Z-0557-2022 · Covidien
Hazard
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 Class II
Units
1,994 devices
Sold at
Worldwide distribution - US Nationwide and the countries of Germany, Israel, Italy, Portugal, Spain, Chile, Singapore, and China.
Description
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.
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
Manufacturer(s)
Covidien Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →