Endologix AFX Introducer System Recalled for Dilator Breakage
Endologix Inc. is voluntarily recalling 53 units of the AFX Introducer System due to reports of dilator breakage during clinical procedures.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures."
Plain-English summary
Endologix, Inc. has initiated a voluntary recall of 53 units of the AFX Introducer System, Model Number S17-45. The recall covers specific lot numbers: 1079840, 1079843, 1079844, and 1079845. The AFX Introducer System is a medical device intended to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.
The recall was initiated due to reports of dilator breakage during clinical procedures. The affected units were distributed worldwide, including nationwide in the United States (specifically in NY, NH, IN, MI, FL, and NJ) and in Europe and Latin America.
Healthcare providers and facilities should stop using the affected lots immediately and contact Endologix, Inc. for instructions on returning the devices. Patients who have had procedures using these specific devices should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize…
- Manufacturer
- Endologix Inc
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 53
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 (4)
- Model Number S17-45. Lot Numbers: 1079840
- 1079843
- 1079844
- 1079845
Distribution
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