AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip — Class II medical device recall Z-1148-2017
Terminated recall by AtriCure, Inc., reported 2017-02-15, distributed in AL, AR, AZ, CA, CO, FL, GA, ID…. A complaint of the PRO2 jaw breaking prior to surgery being performed.
| Recall number | Z-1148-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AtriCure, Inc., Mason, OH, United States |
| Recall initiated | 2016-11-30 |
| Classified | 2017-02-07 |
| Reported by FDA | 2017-02-15 |
| Terminated | 2018-02-15 |
| Distributed | AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WI |
| Countries outside the US | AT, CH, DE, GB, NL, PL, SE |
| Quantity | 464 units |
| Lot numbers | 67102, 68418 |
| Model numbers | PRO235, PRO240, PRO245, PRO250 |
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) single unit PRO2 devices are packaged into one (1) corrugate shipper box.
Reason for recall
A complaint of the PRO2 jaw breaking prior to surgery being performed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1148-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.