Reported Apr 2, 2014 · Terminated
Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos,…
Biocardia, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Biocardia, Inc. · 125 Shoreway Rd Ste B · San Carlos, CA · 94070-2718
Is this the product you have?
Morph AccessPro Steerable Introducer6F Introducer90
- cm working lengthSingle use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature
- Lot codes and dates
- Catalog number MAP690 -lot numbers
1051106310831106111911371138114011461148115111541160116211831186
- Catalog number MAP690 -lot numbers
- Amount recalled
- ~2541 units - both catalog numbers.
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
This product could cause temporary or reversible health problems — stop using it.
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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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