This is an update of FDA's public recall notice on 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 Measurement System , which was issued on December 29, 2010. Additional information about the model and lot numbers affected has been included in this updated document.

Recall Class: Class I

Date Recall Initiated: October 11, 2010

Products:
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

Manufacturing From: January 2009 to October 2010

Distribution From: November 2009 to October 2010

The following model and lot numbers affected can be found using the following List Number Configurations:

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.

Recalling Firm:
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

FDA Comments:

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.

Useful Links:

• Arrow International Urgent Medical Device Recall
• MedWatch: The FDA Safety Information and Adverse Event Reporting Program