FDA (Devices) recall action 84399
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Arrow International Inc is recalling specific Arrow Berman Angiographic Catheters due to a potential leak in the balloon extension line that could cause serious injury or death.
Arrow International Inc. is recalling 71 units of Arrow Berman Angiographic Catheters due to a potential leak in the balloon extension line that could cause serious injury or death.