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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Covidien Llc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0557-2022
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