ClearanceBrief
Recall Z-0862-03 ยท MAF Stent, Coronary

Guidant Corporation ACS

MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13

DateMay 22, 2003 (initiated May 7, 2003)
StatusTerminated
ReasonSterility compromised.
Root causeOther
ActionThe firm initially is notifying by letter dated May 6, 2003 and will plan visit follow-ups to collect quarantined product.
Quantity40
DistributionNATIONWIDE
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.