Recall Z-0557-2022 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Covidien Llc
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
| Date | Feb 3, 2022 (initiated Dec 17, 2021) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 |
| Quantity | 1,994 devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Germany, Israel, Italy, Portugal, Spain, Chile, Singapore, and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163231 | Chameleon PTA Balloon Catheter Av Medical Technologies, Ltd., Jan 17, 2017 |