Agency classClass IIOur severity:High FDA (Devices)·Z-0660-2022·Announced 2022-03-02

Optima Coil System Recalled for Labeling and Packaging Mix-Up

BALT USA recalls Optima Coil System embolization devices due to labeling/pouch mix-up that could result in incorrect device selection during surgical procedures. Potential harms include vessel damage and aneurysm rupture.

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: This is a risk-of-harm product (implantable medical device) where labeling mix-up could lead to incorrect device selection, with potential for vessel damage or aneurysm rupture. The harms described are prospective and potential rather than reported, consistent with FDA Class II scoring of 3 (High).

Plain-English summary

BALT USA, LLC is recalling 51 units of the Optima Coil System due to a labeling and packaging mix-up caused by inadequate manufacturing line clearance. The affected units (Lot Numbers F210500134 and F210500135) were distributed nationwide in Florida and Maryland, as well as internationally to Denmark, France, Germany, Lebanon, Netherlands, Sweden, Peru, Portugal, Slovenia, Spain, and the United Arab Emirates.

The Optima Coil System is an implantable embolization coil used in surgical procedures. Due to incorrect labeling of coil-size pouches and shelf carton labels, healthcare providers could inadvertently select an incorrect coil size for a patient procedure.

If the wrong coil size is selected, potential harms include vessel damage, inability to treat the patient with the device, or rupture of the aneurysm. Affected healthcare facilities and providers should contact BALT USA, LLC immediately to quarantine affected units and verify correct device sizes before use.

The recalled product

Product: The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The…
Manufacturer: BALT USA, LLC
Category: Medical Device — Embolization Coil System
Hazard: mis-labeling
vessel-damage
aneurysm-rupture
treatment-failure
Affected units: 51

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · BALT USA, LLC

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Same hazard · mis labeling