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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- 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
Same hazard · embolic event
See all →- HighPlato 17 Microcatheter Recalled Due to Loose Particle Risk
FDA (Devices) · 2023-03-22
- HighVasoshield Syringe Packs Recalled Due to Chipping Ink Risk
FDA (Devices) · 2023-01-25
- SevereCook Medical Recalls Zilver 518RX Vascular Stent Delivery Systems
FDA (Devices) · 2016-02-03
- HighBaxter Recalls Dual Luer Lock Caps Due to Loose Particulate Matter
FDA (Devices) · 2013-11-13
Similar recalls
- ModerateBiocardia Recalls Morph Accesspro Steerable Introducers Due to Packaging Wear
FDA (Devices) · 2014-02-26
- ModerateMedComp Recalls 9F Plastic Dual Port Vascular Access Devices
FDA (Devices) · 2015-05-06
- HighSterilmed Recalls Reprocessed Agilis Steerable Introducers Due to Endotoxin Concerns
FDA (Devices) · 2018-10-17
- HighGuidewire Introducer Recalled for Manufacturing Defect Affecting Device Function
FDA (Devices) · 2024-03-27
- ModerateFDA Recalls Vascular Guidewire Introducer Due to Manufacturing Defect
FDA (Devices) · 2024-03-27
- ModerateMedComp Recalls 9.6F CT Ports with Incorrect Introducer Size
FDA (Devices) · 2017-03-29