Arrow Recalls Defective Balloon Catheters

<"http://www.yourlawyer.com/practice_areas/defective_medical_devices">Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and Measurement System have been recalled, the U.S. Food and Drug Administration (FDA) just announced. The recall is a Class I, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The recall was initiated on October 11, 2010 and includes the Arrow IAB (Intra Aortic Balloon), Ultra 8 Fr, 30cc
Arrow IAB (Intra Aortic Balloon), Ultra 8 Fr, 40cc
Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System, 30cc
Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor, and a Measurement System, 40cc.

The recalled devices were manufactured from January 2009 to October 2010 and were distributed from November 2009 to October 2010.

A complete listing of model and lot numbers affected can be found using the List Number Configurations, which can be accessed at http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm238402.htm.

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.

The full name and address for the recalling firm is Arrow International, Inc., Division of Teleflex Medical Inc.
9 Plymouth Street, Everett, Massachusetts, 02149-1814.

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 a delay in therapy, bleeding, or arterial injury.

Arrow International is advising customers to immediately discontinue use of any affected products and contact Arrow Customer Service, toll-free, at 1.866.396.2111.

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.

This entry was posted in Defective Medical Devices, Product Recalls, Recalled Medical Devices. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.