Recall Z-0623-2017 ยท DYB Introducer, Catheter
Greatbatch Medical
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
| Date | Nov 18, 2016 (initiated Sep 8, 2016) |
| Status | Terminated |
| 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. |
| 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 FieldActionCenter@Greatbatch.com. |
| Quantity | 23,075 |
| Distribution | US: NY, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071574 | STIFFER COAXIAL MICRO-INTRODUCER KIT Enpath Medical, Inc., Jul 5, 2007 |