Recall Z-0623-2017— Greatbatch Medical

Name: FDA recall Z-0623-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-08

Class II · Terminated

Class II FDA medical device recall by Greatbatch Medical, initiated 2016-09-08, terminated 2017-09-08. It names one FDA 510(k) clearance: K071574. Product: 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: 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..

Recalling firm: Greatbatch Medical
Classification: Class II
Status: Terminated
Initiated: 2016-09-08
Terminated: 2017-09-08
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K071574 — STIFFER COAXIAL MICRO-INTRODUCER KITEnpath Medical, Inc.·cleared 2007-07-05

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

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.

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