Z-1907-2008

Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-KS, Lot number RF8015919, 5 Fr. (110 cm)...

Name: Z-1907-2008 Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-KS, Lot number RF8015919, 5 Fr. (110 cm)...
Creator: Arrow International Inc
Published: 2008-04-01
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2008-04-01 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of 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... on 2008-04-01. The reason FDA records is "The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1907-2008
Status: Terminated
Initiated: 2008-04-01
Posted: 2008-09-16
Terminated: 2009-12-08
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
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.
Product code: LDF Electrode, Pacemaker, Temporary
Reason for recall: The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly.
Root cause tag: manufacturing process
FDA 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 in commerce: 686 kits (286 kits of AI-07155-KS in the US + 400 kits of AI-07155-IK internationally)
Distribution: U.S. South Africa, Venezuela
Product codes and lots: Part number: AI-07155-KS, Lot number RF8015919 (Distributed in the U.S.)

Product code LDF

K960479Class IIArrow Bipolar Pacing/balloon Wedge Pressure CatheterArrow Intl., Inc. / cleared 1996-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)