The Recall Desk
HighFDA (Devices)·Z-2070-2021·Announced 2021-07-21

Arrow Bipolar Balloon Electrode Catheter Recalled for Marketing Without FDA 510K Clearance

Arrow International is recalling 4 units of an electrode catheter marketed without FDA 510(k) clearance. The device was intended for electrophysiology studies.

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: FDA Class II recall for a medical device marketed without required 510(k) clearance. This represents a risk-of-harm product where injury has not been reported. Regulatory non-compliance in device approval is significant even without reported incidents.

Plain-English summary

Arrow International Inc is recalling 4 units of the Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm (Product Code AI-07154, Lot Number 16F19J0109). The device is intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

The device was marketed without obtaining required FDA 510(k) clearance. This regulatory violation indicates the device was distributed without FDA review and approval.

The recalled units were distributed nationwide across Florida, Idaho, Illinois, New York, Ohio, and Texas.

Facilities using this device should contact Arrow International Inc for further instructions. No illnesses or injuries related to this device have been reported.

The recalled product

Product
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Manufacturer
Arrow International Inc
Category
Medical Device — Electrophysiology Catheter
Hazard
  • regulatory-non-compliance

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: 16F19J0109

Distribution

Distributed nationwide across the United States.

Related recalls

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