Z-0623-2017Class II

Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR...

Name: Z-0623-2017 Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR...
Creator: Greatbatch Medical
Published: 2016-09-08
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2016-09-08 / Terminated / root cause: manufacturing process

FDA source

Greatbatch Medical began a recall of Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR. The... on 2016-09-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0623-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-08
Posted: 2016-11-18
Terminated: 2017-09-08
Recalling firm: Greatbatch Medical
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.
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Greatbatch sent a "Urgent Medical Device Recall" letter dated September 7, 2016 to all affected customers .The letter described the product, "Reason for Field Correction Action", "Risk to Health" , "Replacement Devices", & "Instructions to Customers" . Advised customers to quarantine the product and contact end users and share the recall information with them. Requested consignees to complete & return the Field Recall Response Form. For questions contact your local Greatbatch Medical representative, contact us at 1-763-951-8235, or e-mail us at [email protected].
Quantity in commerce: 23,075
Distribution: US: NY, TX.
Product codes and lots: GBP3176925, GBP3176927, VN3470927, VN3470929, VN3486000, VN3485998, VN3495047, GBP3421664, VN3433259, VN3451654, VN3487654, VN3491069, VN3470925, VN3451646.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0623-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0623-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-18

Product code DYB

K071574Class IIStiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. / cleared 2007-07-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)