Morph AccessPro Steerable Introducer recall: Particulate Matter
Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph…
Why was Morph AccessPro Steerable Introducer recalled?
Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog number MAP690 -lot numbers: 1051 1063 1083 1106 1119 1137 1138 1140 1146 1148 1151 1154 1160 1162 1183 1186
- Product
- Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph…
- Recalling firm
- Biocardia, Inc.
- Quantity
- ~2541 units - both catalog numbers.
- Distribution
- Worldwide Distribution: US (nationwide) and country of: Israel.
- Recall date
- April 2, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)