Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-KS, Lot number RF8015919, 5 Fr. (110 cm) Pacing Catheter, 6 Fr. Introducer Sheath, .035 inch diameter spring-wire guide, Single use. The device is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart.
FDA Recall Z-1907-2008 · Posted 2008-09-16
Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeLDF
Date Initiated2008-04-01
Date Terminated2009-12-08
Product Quantity686 kits (286 kits of AI-07155-KS in the US + 400 kits of AI-07155-IK internationally)
Reason for Recall
The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly.
Firm Action
Consignees were notified by letter on/about 04/11/ 2008. They were instructed to cease use and distribution, and quarantine all affected product. They were also instructed to complete an enclosed Acknowledgement & Stock Status Form and fax back to Arrow International. Consignees were further advised to communicate the recall notice to anyone who has received the affected product by providing a copy of the recall notice to their customer(s).
Contact Arrow International, Customer Relations Department at 800-523-8446 if you have questions.
Root Cause
Process control
Distribution Pattern
U.S. South Africa, Venezuela
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.