Reported Mar 16, 2016 · Terminated
Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation…
Arrow International, Inc., Division of Teleflex Medical Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Arrow International, Inc., Division of Teleflex Medical Inc. · 9 Plymouth St · Everett, MA · 02149-1814
Is this the product you have?
- Ultra 8 IAB8Fr 30cc
- Product CodeIAB-05830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle
- Lot codes and dates
- Batch
18F14A003118F14A003218F14A003318F14D006618F14E001818F14E007218F14F006718F14F007918F14G004518F14G004618F14G008118F14H003718F14J002318F14L001418F14M003318F15A001018F15B001518F15C000418F15C002318F15D002518F15D005218F15E002018F15F000218F15F003918F15G000518F15G001518F15H000618F15H003718F15H005118F15J002618F15L000718S14G0046
- Batch
- Amount recalled
- 13,405 US and 33,735 OUS in total
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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