TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Hea

FDA device recall Z-0391-2019 · posted 2018-11-08 · Terminated

Recall details

Recalling firm

Oscor, Inc.

Reason for recall

During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.

Action taken

A press release for the recall was issued on 09/27/2018. Additionally, starting on about 09/26/2018, Oscor notified customers via email and mail with a "PRODUCT RECALL - ACTION REQUIRED" letter. For distributors, instructions included to examine inventory for affected devices, quarantine any affected devices, notify customers if the affected devices have been further distributed, retrieve those affected devices from customers, and complete and return the attached Exhibit A. Any affected devices on hand and at customers should not be destroyed, but returned to Oscor. For hospitals, instructions included to examine inventory for affected devices, quarantine any affected devices, and complete and return the attached Exhibit A. Any affected devices on hand and at customers should not be destroyed, but returned to Oscor. Questions can be directed to TB Recall Coordinator at 727-937-2511 or e-mail TB@Oscor.com. Oscor business hours are Monday to Friday from 8:30AM to 5:30PM Eastern Time. On 11/07/2018 Oscor expanded the recall and notified customers via "PRODUCT RECALL - ACTION REQUIRED" letter and press release. The expansion includes expired devices distributed by Oscor from 12/21/2011 to 04/30/2015, to result in affected devices distributed from 12/21/2011 to 05/17/2018. Instructions for distributors and hospitals remain the same as the original notification.

Root cause

Device Design

Status

Terminated

Product code

LDF

Quantity affected

36,688 units

Distribution

Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, HI, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PR, RI, TN, TX, UT, VA, WA. Countries of AUSTRIA, BE

Date initiated

2018-09-26

Date posted

2018-11-08

Date terminated

2022-08-04

Location

Palm Harbor, FL

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