CLASS II Device recall · Reported 26 Sep 2018 · FDA Enforcement Report
Arrow¿ Bipolar Electrode Catheter with shrouded pins Product recalled
Arrow International is recalling Arrow¿ Bipolar Electrode Catheter with shrouded pins Product, distributed in Pennsylvania. The recall was initiated on 30 Jul 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3197-2018
- FDA event ID
- 80872
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jul 2018
- FDA classified
- 19 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 30 Jul 2018 | Recall initiated by company | |
| 19 Sep 2018 | Classified by FDA | +51 days |
| 26 Sep 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products are labeled with an incorrect expiration date
Product as listed by the FDA
ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording
Where it was distributed
US in the state of PA
Questions about this recall
Is Arrow¿ Bipolar Electrode Catheter with shrouded pins Product recalled?
Yes. Arrow International recalled Arrow¿ Bipolar Electrode Catheter with shrouded pins Product on 30 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-3197-2018.
Why was it recalled?
Products are labeled with an incorrect expiration date
Which lots are affected?
Lot/Batch Number:16F18A0010 Use By: 2023-12-31
Where was it sold?
US in the state of PA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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