FDA recall Z-0580-2020

Product

Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.

Reason for recall

Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

Distribution

Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.

Key facts

Status

Terminated

Initiation date

2019-10-24

Report date

2019-12-04

Termination date

2023-03-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0580-2020