FDA Device recall Z-1148-2017
AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed pol…
- FDA Device
- Class II
- terminated
- Published 2017-02-15
On 2017-02-15 the FDA classified a Class II recall of AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed pol… by Atricure, citing A complaint of the PRO2 jaw breaking prior to surgery being performed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1148-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-30 |
| Published | 2017-02-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Atricure |
| Distribution | 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 |
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
A complaint of the PRO2 jaw breaking prior to surgery being performed.
Identifiers
| code_info | Model Numbers: PRO235, PRO240, PRO245, PRO250 Lot Numbers: 67102 to 68418 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1148-2017%22
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