BioCardia Morph AccessPro Steerable Introducer Recalled for Particulate Risk
BioCardia is recalling Morph AccessPro Steerable Introducers due to potential particulates in the inner lumen that could cause an embolic event.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of an embolic event, which is a significant injury risk, meeting the criteria for a Severe rating.
Plain-English summary
BioCardia, Inc. is recalling approximately 2,541 units of the Morph AccessPro Steerable Introducer (6F, 45 cm working length). The recall involves catalog number MAP645 and specific lot numbers listed in the agency record. The product is a single-use medical device intended to provide a pathway for other instruments within 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 affected units were distributed worldwide, including nationwide in the United States and in Israel.
Healthcare providers and facilities should stop using the affected lots immediately and contact BioCardia, Inc. for further instructions on return or disposal. Patients who have had this device used during a procedure should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Morph AccessPro Steerable Introducer; 6F Introducer, 45 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 th
- 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 →- HighBioCardia Recalls Morph AccessPro Steerable Introducers Due to 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