Arrow Intra-Aortic Balloon (IAB) Catheter Products: Class 1 Recall - Catheters Can Become Stuck in the Sheath
[UPDATED 01/27/2011] Additional information about the model and lot numbers affected has been included in an updated Class I Recall Notice.
AUDIENCE: Risk Manager, Surgery
ISSUE: The Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System are recalled because the catheters can become stuck in the sheath. When the IAB catheter becomes stuck, the user is unable to move the IAB catheter forward or backward, causing delay in therapy, bleeding or arterial injury.
BACKGROUND: The Arrow IAB products are used in the treatment of a variety of cardiac conditions, including heart failure, septic shock, and myocardial infarction. They are also used to support and stabilize high-risk patients undergoing diagnostic and non-surgical procedures. For model and lot numbers affected please see the recall notice.
RECOMMENDATION: Customers are advised to immediately discontinue use of any affected products.
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.htm
- 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