Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm recall: Foreign Material
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…
Why was Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Covidien Llc
- Quantity
- 1,994 devices
- Distribution
- Worldwide distribution - US Nationwide and the countries of Germany, Israel, Italy, Portugal, Spain, Chile, Singapore, and China.
- Recall date
- February 9, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)