AtriCure Recalls AtriClip LAA Exclusion System Due to Jaw Breakage
AtriCure is recalling 464 AtriClip LAA Exclusion System devices because a complaint was received regarding the PRO2 jaw breaking prior to surgery.
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 mechanical failure of a medical device prior to surgery. As no injuries or illnesses are explicitly reported in the source text, the risk of harm is theoretical, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
AtriCure, Inc. is recalling 464 units of the AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip. The recall is being conducted because a complaint was received stating that the PRO2 jaw broke prior to the surgery being performed.
The affected devices include model numbers PRO235, PRO240, PRO245, and PRO250, with lot numbers ranging from 67102 to 68418. These devices were distributed in 31 U.S. states and in Austria, Germany, the Netherlands, Poland, Sweden, Switzerland, and the United Kingdom.
Healthcare providers and patients should stop using the affected devices and contact AtriCure, Inc. for further instructions on how to return or replace the product.
The recalled product
- Product
- AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek¿ lid. A single-walled non-corrugated box completes the single unit package. Six (6)…
- Manufacturer
- AtriCure, Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 464
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 (4)
- Model Numbers: PRO235
- PRO240
- PRO245
- PRO250 Lot Numbers: 67102 to 68418
Distribution
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