BioCardia Recalls Morph AccessPro Steerable Introducers Due to Particulate Risk
BioCardia, Inc. is recalling Morph AccessPro Steerable Introducers because particulates in the inner lumen could cause an embolic event.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential embolic event) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
BioCardia, Inc. is recalling approximately 2,541 units of the Morph AccessPro Steerable Introducer, catalog number MAP690. The affected lots include 1051, 1063, 1083, 1106, 1119, 1137, 1138, 1140, 1146, 1148, 1151, 1154, 1160, 1162, 1183, and 1186. These single-use medical devices are intended to provide a pathway for other instruments into the peripheral vasculature.
The recall was initiated after the firm discovered the potential for particulates in the inner lumen of the device. The presence of these particulates could result in an embolic event. The agency has classified this as a Class II recall.
The affected products were distributed worldwide, including nationwide in the United States and in Israel. Healthcare providers and facilities should stop using the affected devices and contact BioCardia, Inc. for further instructions.
The recalled product
- Product
- Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single 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
- Manufacturer
- Biocardia, Inc.
- Affected units
- 2,541
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Biocardia, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Biocardia, Inc.
See all →- SevereBioCardia Morph AccessPro Steerable Introducer Recalled for Particulate Risk
FDA (Devices) · 2014-04-02
- ModerateBiocardia Recalls Morph Accesspro Steerable Introducers Due to Packaging Wear
FDA (Devices) · 2014-02-26
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