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.
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.
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.
The catheter's balloon protector sleeve can be difficult to remove without excessive force. If the sleeve gets damaged during removal, the catheter may cause vessel perforation, foreign body presence, embolism, or delay treatment when used in a patient.
Healthcare professionals who use these catheters for procedures are most at risk, particularly those who have the specific product numbers listed in the recall.
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.
Look for product numbers CH08-40-75GB or CH08-40-75US on the catheter packaging to confirm if it is affected.
Covidien has received six complaint reports indicating difficulty removing the balloon protector sleeve, which could damage the catheter and cause patient harm if used after removal.
If the sleeve is damaged during removal, the catheter may cause vessel perforation, foreign body presence, embolism, or delay treatment when used in a patient procedure.
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.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0557-2022 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0557-2022 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
