Arrow Bipolar Pacing/Balloon Wedge Pressure Catheter

• • Ongoing Z-2383-2026 FDA Class I ·initiated 21 Apr 2026

  Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

• • Terminated Z-1500-2009 FDA Unclassified (pre-2012) ·initiated 11 Feb 2009

  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.

• 2 recalls, same reason

  • Terminated Z-1908-2008 FDA Unclassified (pre-2012) ·initiated 1 Apr 2008
  • Terminated Z-1907-2008 FDA Unclassified (pre-2012) ·initiated 1 Apr 2008

  The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly.

510(k) Number

K960479 ↗

FDA Product Code

LDF

Device Class

Class II

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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