CLASS II Device recall · Reported 30 Nov 2016 · FDA Enforcement Report
Greatbatch Stiffer Coaxial Micro-Introducer recalled
Greatbatch Medical is recalling Greatbatch Stiffer Coaxial Micro-Introducer, distributed in New York, Texas. The recall was initiated on 8 Sep 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0623-2017
- FDA event ID
- 75145
- Recalling firm
- Greatbatch Medical, Plymouth, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Sep 2016
- FDA classified
- 18 Nov 2016
- Reported
- 30 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 8 Sep 2016 | Recall initiated by company | |
| 18 Nov 2016 | Classified by FDA | +71 days |
| 30 Nov 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
US: NY, TX.
Questions about this recall
Is Greatbatch Stiffer Coaxial Micro-Introducer recalled?
Yes. Greatbatch Medical recalled Greatbatch Stiffer Coaxial Micro-Introducer on 8 Sep 2016. The recall is Class II and its status is Terminated. Recall number Z-0623-2017.
Why was it recalled?
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.
Which lots are affected?
GBP3176925, GBP3176927, VN3470927, VN3470929, VN3486000, VN3485998, VN3495047, GBP3421664, VN3433259, VN3451654, VN3487654, VN3491069, VN3470925, VN3451646.
Where was it sold?
US: NY, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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