FDA recall Z-2782-2017

Greatbatch Medical · Class II · device

Product

Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The kit includes a flexible catheter dilator to facilitate bi-directional guiding sheath passage.

Reason for recall

One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.

Distribution

Key facts

Status: Terminated
Initiation date: 2017-02-15
Report date: 2017-08-09
Termination date: 2019-05-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2782-2017