Greatbatch Medical: Medical Device Recall in 2016 - (Recall #: Z-0623-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 8, 2016

Date Posted: November 30, 2016

Recall Number: Z-0623-2017

Event ID: 75145

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.

Status: Terminated

Product Quantity: 23,075

Code Information:

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

Distribution Pattern:

US: NY, TX.

Voluntary or Mandated:

Voluntary: Firm initiated