The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0830-2019·Announced 2019-02-20

AtriCure Recalls COBRA FUSION 150 Ablation System Due to Thromboembolism Risk

AtriCure is recalling 6,176 units of the COBRA FUSION 150 Ablation System because patients may face an elevated risk of thromboembolism during specific off-pump procedures.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 significant injury risk (thromboembolism) in a medical device, which aligns with the 'Severe' criteria for significant injury reports or high-risk device defects.

Plain-English summary

AtriCure, Inc. is recalling 6,176 units of the COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001. The recall covers all lots within their expiry dates. The devices were distributed across numerous U.S. states and internationally to countries including Germany, Italy, the Netherlands, France, Austria, the United Kingdom, Poland, the Czech Republic, the United Arab Emirates, Sweden, Switzerland, Kuwait, Belgium, and Latvia.

The recall was initiated because there is a potential for patients undergoing ablation to experience an elevated risk for thromboembolism (TE). This specific risk is associated with stand-alone off-pump procedures where cardiopulmonary bypass (CPB) was not utilized. The FDA has classified this recall as Class II.

Healthcare providers and facilities that have received these devices should stop using them and contact AtriCure, Inc. for instructions on how to return or dispose of the product. Patients who have already undergone procedures using this device should consult their healthcare provider if they have concerns about potential complications.

The recalled product

Product
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
Manufacturer
AtriCure, Inc.
Category
Medical Device — Cardiovascular
Hazard
Affected units
6,176

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI - none Lot Numbers - All lots within expiry

Distribution

Distributed in 37 states:

Part of a larger recall action

This product is one of 4 recalled by AtriCure, 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 4 products in this recall →

Related recalls

Same manufacturer · AtriCure, Inc.

See all →

Same hazard · thromboembolism

See all →

Similar recalls