Use: 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 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.
Arrow International, Inc.,
Division of Teleflex Medical Inc.
9 Plymouth Street
Everett, Massachusetts 02149-1814
Reason for Recall: The IAB 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.
Public Contact: Michael A. Douglass, Director of Quality Assurance at 617-389-6400
FDA District: New England
Arrow International is advising customers to immediately discontinue use of any affected products and contact Arrow Customer Service at 866-396-2111.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experience using these products to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.