Agency classClass IIOur severity:High FDA (Devices)·Z-2126-2014·Announced 2014-08-06

Baxter Recalls FlowCOUPLER Implantable Devices for Potential Signal Loss

Baxter Healthcare is recalling 1,315 FlowCOUPLER implantable devices because some units may lose electrical continuity, preventing proper monitoring of blood flow.

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 is classified as FDA Class II, and the hazard involves a risk of harm (inability to monitor blood flow) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Baxter Healthcare Corporation is recalling 1,315 units of the FlowCOUPLER Device. This implantable device is used to detect blood flow in vessels and confirm vessel patency during microsurgical and vascular reconstructive procedures. The affected units were distributed worldwide, including in the United States, United Kingdom, Germany, Sweden, Spain, Israel, and Denmark.

The recall was initiated because there is a possibility that some units may not maintain electrical continuity during handling, both intra-operatively and post-operatively. This defect can result in a loss of Doppler signal, which may prevent healthcare providers from appropriately monitoring anastomotic patency and blood flow.

Healthcare providers and patients should contact Baxter Healthcare for instructions on how to manage the affected devices. The recall covers specific lot numbers and part numbers identified in the agency's documentation.

The recalled product

Product: FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and…
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Implantable Diagnostic Device
Hazard: signal-loss
monitoring-failure
Affected units: 1,315

Distribution

Distributed nationwide across the United States.

Same manufacturer · Baxter Healthcare Corporation

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