Class 2 Device Recall Chameleon PTA Balloon Dilation Catheter

• Date Initiated by Firm: December 17, 2021
• Date Posted: February 03, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0557-2022
• Recall Event ID: 89418
• 510(K)Number: K163231
• Product Classification: Catheter, angioplasty, peripheral, transluminal - Product Code LIT
• 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
• Code Information: 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
• Recalling Firm/ Manufacturer: Covidien Llc; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: Customer Service; 800-962-9888
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 1,994 devices
• Distribution: Worldwide distribution - US Nationwide and the countries of Germany, Israel, Italy, Portugal, Spain, Chile, Singapore, and China.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LIT and Original Applicant = AV Medical Technologies Ltd