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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: GBP3176925, GBP3176927, VN3470927, VN3470929, VN3486000, VN3485998, VN3495047, GBP3421664, VN3433259, VN3451654, VN3487654, VN3491069, VN3470925, VN3451646.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Greatbatch Medical
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 Codes/Lot Numbers:
GBP3176925, GBP3176927, VN3470927, VN3470929, VN3486000, VN3485998, VN3495047, GBP3421664, VN3433259, VN3451654, VN3487654, VN3491069, VN3470925, VN3451646.
Distribution:
Distributed in: US, NY, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0623-2017
Related Recalls
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Greatbatch Medical
Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.
Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp Handle) and EZ Clean" Linear Broach Handle. Greatbatch Medical has received reports that that the product is breaking at the welds and that the locating pin at the distal end of the instrument is breaking off during use.