Home / Recalls / Greatbatch Medical / Z-2781-2017

Z-2781-2017 Class II Terminated

Recalled by Greatbatch Medical — Plymouth, MN

Recall Details

Product Type
Devices
Report Date
August 9, 2017
Initiation Date
November 11, 2016
Termination Date
November 3, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,000 devices

Product Description

ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006

Reason for Recall

Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.

Distribution Pattern

NY

Code Information

Lot Number: W3101005

Other recalls by Greatbatch Medical

  • Z-2055-2017 Class II — Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgi (April 23, 2017)
  • Z-2782-2017 Class II — Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small cu (February 15, 2017)
  • Z-1190-2017 Class II — Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable (October 19, 2016)
  • Z-0623-2017 Class II — Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Co (September 8, 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)