Greatbatch Stiffer Coaxial Micro-Introducer — Class II medical device recall Z-0623-2017
Terminated recall by Greatbatch Medical, reported 2016-11-30, distributed in NY, TX. Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field
| Recall number | Z-0623-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Greatbatch Medical, Plymouth, MN, United States |
| Recall initiated | 2016-09-08 |
| Classified | 2016-11-18 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2017-09-08 |
| Distributed | NY, TX |
| Quantity | 23,075 |
| Reason classes | device malfunction |
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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.