FDA Medical Device Recalls (openFDA)
Arrow International Inc: 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.
- Recall number
- Z-1907-2008
- Recalling firm
- Arrow International Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2008-04-01
- Posted
- 2008-09-16
- Terminated
- 2009-12-08
- Reason
- The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly.
- Root cause
- Process control
- 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.
- Quantity
- 686 kits (286 kits of AI-07155-KS in the US + 400 kits of AI-07155-IK internationally)
- Distribution
- U.S. South Africa, Venezuela
- Lot, serial or model codes
- Part number: AI-07155-KS, Lot number RF8015919 (Distributed in the U.S.)
- 510(k) numbers
- ["K960479"]
- PMA numbers
- not on file
- Product code
- LDF
- Firm FEI
- 1036844
- Firm city
- Asheboro
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28