AUDIENCE: Risk Manager, Surgery
ISSUE: A manufacturing error caused the balloon inflation ports to be mislabeled. This may cause the physician using the device to deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs. See the FDA Class I Recall Notice for a complete list of affected model and lot numbers.
Depending upon the size of these clots, there is the possibility of serious patient injury or death.
BACKGROUND: The Trellis 6 and Trellis 8 Peripheral Infusion systems are used to treat blood clots that may form in the veins or arteries of the arms, hands, legs, or feet. The systems have two balloons that are inflated to isolate a clot. Medication is released between the balloons to reduce the size of or dissolve the clot so it can be removed. These devices are used by health care providers.
RECOMMENDATION: Customers were sent an urgent product recall letter dated December 15, 2014. The letter identified the affected product and actions for customers. Customers should discontinue the use of the Trellis 6 and 8 infusion systems and return it to Covidien along with a response form included in the letter. Customers with questions should contact their Covidien sales rep or Covidien Service at 1-800-716-6700.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[01/22/2015 - Recall Notice - FDA]