CLASS II Device recall · Reported 25 Dec 2019 · FDA Enforcement Report
Arrow Berman Angiographic Catheter recalled by Arrow International
Arrow International is recalling Arrow Berman Angiographic Catheter, distributed nationwide in the US. The recall was initiated on 15 Nov 2019 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-0716-2020
- FDA event ID
- 84399
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Nov 2019
- FDA classified
- 19 Dec 2019
- Reported
- 25 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 15 Nov 2019 | Recall initiated by company | |
| 19 Dec 2019 | Classified by FDA | +34 days |
| 25 Dec 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
Where it was distributed
U.S. Nationwide, Canada
Questions about this recall
Is Arrow Berman Angiographic Catheter recalled?
Yes. Arrow International recalled Arrow Berman Angiographic Catheter on 15 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-0716-2020.
Why was it recalled?
Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death
Which lots are affected?
Lot Number: 16F19H0093
Where was it sold?
U.S. Nationwide, Canada
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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