Recall Z-2782-2017— Greatbatch Medical

Name: FDA recall Z-2782-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-15

Class II · Terminated

Class II FDA medical device recall by Greatbatch Medical, initiated 2017-02-15, terminated 2019-05-09. It names one FDA 510(k) clearance: K130559. 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: One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed..

Recalling firm: Greatbatch Medical
Classification: Class II
Status: Terminated
Initiated: 2017-02-15
Terminated: 2019-05-09
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K130559 — MOBICATH BI-DIRECTIONAL GUIDING SHEATHGreat Batch Medical·cleared 2013-05-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.