The Recall Desk
HighFDA (Devices)·Z-2071-2021·Announced 2021-07-21

Arrow Temporary Pacing Catheter Distributed Without FDA 510K Clearance

Arrow International is recalling its Temporary Pacing Catheter/Introducer Kit because it was marketed without required FDA 510K clearance. Approximately 15 units were distributed in multiple U.S. states.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II medical device for cardiac procedures was distributed without FDA 510K premarket clearance, making it an unverified risk-of-harm product. Although no illnesses or injuries have been reported, the regulatory violation prevents verification of the device's safety and effectiveness.

Plain-English summary

Arrow International Inc is recalling the Arrow Temporary Pacing Catheter/Introducer Kit (Product Code AI-07155-IK) because it was marketed without FDA 510K clearance. The kit includes a 5 French pacing catheter and 6 French introducer for use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

The device was marketed without FDA 510K premarket notification, a required step in the FDA approval process for medical devices in this classification.

Approximately 15 units were distributed in the United States, including the states of Florida, Idaho, Illinois, New York, Ohio, and Texas. The affected lot numbers are 23F20A0230, 23F20E0004, and 23F20E0094.

Healthcare facilities and providers should immediately cease use of affected units and contact Arrow International Inc for instructions on return or replacement of the product.

The recalled product

Product
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Manufacturer
Arrow International Inc
Category
Medical Device — Cardiac / Pacing
Hazard
  • regulatory-violation
  • missing-510k-clearance

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers: 23F20A0230 23F20E0004 23F20E0094

Distribution

Distributed nationwide across the United States.

Related recalls

Same category