Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZI

FDA device recall Z-1844-2019 · posted 2019-06-19 · Terminated

Recall details

Recalling firm

Cook Inc.

Reason for recall

may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in the Instructions for Use (IFU). Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention.

Action taken

Urgent Medical Device Recall notification letters dated 4/26/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns, contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.

Root cause

Under Investigation by firm

Status

Terminated

Product code

MIH

Quantity affected

1027

Distribution

No US distribution. Product distributed to the following foreign countries: Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile Columbia, Costa Rica, Czech Republic, Denmark, Finland, F

Date initiated

2019-04-26

Date posted

2019-06-19

Date terminated

2019-11-08

Location

Bloomington, IN