Recall Z-1206-2022— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Name: FDA recall Z-1206-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-20

Class II · Ongoing

Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2022-04-20. It names one FDA 510(k) clearance: K183493. Product: The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove the deflectable catheter. The deflectable catheter is designed for placement of transvenous devices in or near the bundle of His. It features a deflecting distal section, controlled by the deflectable catheter handle, and an out-of plane curve on the distal tip. The body of the deflectable catheter is radiopaque for visibility on fluoroscopy.. Reason: The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility..

Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Classification: Class II
Status: Ongoing
Initiated: 2022-04-20
Firm location: Mounds View, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K183493 — SelectSite C304-HIS Deflectable Catheter SystemMedtronic, Inc.·cleared 2019-03-15

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

The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove the deflectable catheter. The deflectable catheter is designed for placement of transvenous devices in or near the bundle of His. It features a deflecting distal section, controlled by the deflectable catheter handle, and an out-of plane curve on the distal tip. The body of the deflectable catheter is radiopaque for visibility on fluoroscopy.

Reason for recall

The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.

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