Home / Recalls / Greatbatch Medical / Z-0623-2017

Z-0623-2017 Class II Terminated

Recalled by Greatbatch Medical — Plymouth, MN

Recall Details

Product Type
Devices
Report Date
November 30, 2016
Initiation Date
September 8, 2016
Termination Date
September 8, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23,075

Product Description

Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR. The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consists of a dilator and sheath, available in 4FR and 5FR. The inner dilator includes a stainless steel stiffening hypotube. The Coaxial Micro-Introducer is indicated for percutaneous introduction of up to a 0.038 in. guidewire or catheter into the vascular system through an initial puncture of a 21G introducer. The device is sold to customers in a bulk non-sterile configuration.

Reason for Recall

Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use.

Distribution Pattern

US: NY, TX.

Code Information

GBP3176925, GBP3176927, VN3470927, VN3470929, VN3486000, VN3485998, VN3495047, GBP3421664, VN3433259, VN3451654, VN3487654, VN3491069, VN3470925, VN3451646.

Other recalls by Greatbatch Medical

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  • Z-2782-2017 Class II — Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small cu (February 15, 2017)
  • Z-2781-2017 Class II — ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 (November 11, 2016)
  • Z-1190-2017 Class II — Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable (October 19, 2016)
  • Z-0367-2017 Class I — Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl06 (August 2, 2016)
  • Z-1884-2016 Class II — Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed b (April 26, 2016)
  • Z-1882-2016 Class II — Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Cus (April 26, 2016)
  • Z-1883-2016 Class II — Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non (April 26, 2016)
  • Z-1614-2014 Class II — Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Orde (April 28, 2014)
  • Z-1119-2014 Class I — Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, (January 31, 2014)