Greatbatch Stiffer Coaxial Micro-Introducer Recalled for Detaching Luer
Greatbatch Medical is recalling Stiffer Coaxial Micro-Introducers because a rotating luer detached from the dilator hub during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a mechanical failure of a medical device used in vascular procedures, which poses a risk of harm, but no injuries or illnesses are reported in the source text.
Plain-English summary
Greatbatch Medical is recalling the Stiffer Coaxial Micro-Introducer, models 10904-001 (4FR) and 10904-002 (5FR). The recall was initiated after a field complaint reported that the rotating luer detached from the dilator hub during use.
The device is a radiopaque micro-introducer consisting of a dilator and sheath, indicated for percutaneous introduction of a guidewire or catheter into the vascular system. It is sold in a bulk non-sterile configuration. The recall covers 23,075 units distributed in New York and Texas.
Healthcare facilities and customers should stop using the affected devices and contact Greatbatch Medical for further instructions.
The recalled product
- 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.…
- Manufacturer
- Greatbatch Medical
- Category
- Medical Device — Vascular Access
- Affected units
- 23,075
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- GBP3176925
- GBP3176927
- VN3470927
- VN3470929
- VN3486000
- VN3485998
- VN3495047
- GBP3421664
- VN3433259
- VN3451654
- VN3487654
- VN3491069
- VN3470925
- VN3451646.
Distribution
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