—#81573

Product

Arrow Balloon and stylet temporary pacing catheter

FDA product code: LDF — Electrode, Pacemaker, Temporary
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K960479
Affected lot / code info: All lots of Product codes listed in Z-1489-2009.

Why it was recalled

Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.

Root cause (FDA determination)

Device Design

Action the firm took

Arrow International issued a letter dated 2/18/09 to all customers informing them of the problem and if a lipid resistant stopcock is required to contact the firm for replacements. New labels state: Warning - do not use with lipid containing solutions or 70% isopropyl alcohol, as these solutions may cause leakage or air embolism.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern: Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Singapore, Slovakia, South Africa, South Korea, Spain, Sri lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, and Venezuela.

Timeline

Recall initiated: 2009-02-11
Posted by FDA: 2009-06-24
Terminated: 2010-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81573. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.