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.
FDA Recall Z-0623-2017 · Posted 2016-11-18
Recalling FirmGreatbatch Medical
Recall StatusTerminated
Product CodeDYB
Date Initiated2016-09-08
Date Terminated2017-09-08
Product Quantity23,075
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.
Firm 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].
Root Cause
Process design
Distribution Pattern
US: NY, TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.