RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Apr. 13, 2009--
Teleflex Medical announced today that the U.S. Food and Drug
Administration (FDA) has classified the voluntary medical device recall
initiated on February 2, 2009 by Arrow International’s Cardiac Care
Division involving volume connectors for its 30cc, 40cc and 50cc Intra
Aortic Balloon Pump (IAB) Catheters as a Class 1 recall. FDA defines
Class I recalls as, “a situation in which there is a reasonable
probability that the use of or exposure to a violative product will
cause serious adverse health consequences or death.”
This recall is being conducted because a fault in the connector of the
pump tubing assembly may result in the volume setting on the pump
defaulting to 2.5 cc or 5 cc, rather than the appropriate 30, 40, or 50
cc volume. In patients exhibiting moderate to severe myocardial ischemia
or low perfusion states, prolonged exposure to the low default volume
may fail to decrease ischemia and increase perfusion, leading to organ
injury or infarct and may result in patient death. Prolonged exposure to
a device which is inflated to less than 2/3 full could also result in
thrombus formation on the IAB and possible subsequent systemic or
cerebral thromboembolism.
Instructions contained in the operator’s manual fully describe the
necessary warnings and precautions that will identify the issue. The
recall notice restates these instructions and references the sections in
the owner’s manual. If these instructions are followed, the issue for
which the product was recalled can be discovered immediately, and the
product can be removed and replaced.
Arrow International notified both domestic and foreign hospitals and
distributors via an Urgent Medical Device recall letter dated February
2, 2009 that the company had become aware that the blue connector for
the 40cc IAB was not properly recognized by the Arrow Intra-Aortic
Balloon Pump (IABP) system. This recall involved the retrieval of unused
product, issuance of mitigation instructions for patients and/or
facilities in critical need, and the replacement of pump tubing
assemblies.
At this time, there have been 25 complaints of this issue. There have
been no reports of patient injury as a result of this issue. Approx. 423
lots are affected by this recall for a total 45,211 units.
PRODUCTS AFFECTED: 30/40/50 CC IAB Catheters:
PRODUCT CODES: IAB-04830-U, IAB-04840-U, IAB-05830-LWS,
IAB05830-U,
IAB-05840-U, IAB-05840-LWS, IAB06830-U, IAB06840-U,
IAB-S730C,
IAB-S840C, IAB-R950-U, IAK-02692, IAK-02693, and IAK-02691.
A list of products and lot numbers affected by this recall as well as
the original recall notice can be found at Arrow’s website:
http://www.arrowintl.com/iab_recall.asp
Consumers with questions may contact the company at 1-800-523-8446; 8am
to 8pm, ET, Monday through Friday, for international calls
001-919-361-4062; 8am to 5pm, ET, Monday through Friday.
Any adverse reactions experienced with the use of this product, and/or
quality problems can also be reported to the FDA’s MedWatch Program by
phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch,
HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the
MedWatch website at www.fda.gov/medwatch.
Source: Teleflex Medical
Teleflex Incorporated
Investors:
Jake Elguicze
Senior
Director
Investor Relations
610-948-2836
or
Teleflex
Medical
Media:
Julie McDowell
VP Global Communications
610-948-2829