Worker™ Guidewire 110135080Recalls & reported problems

Argon Medical Devices, Inc. · Worker™ Guidewire - Standard Straight 0.035"/80cm/3.5cm · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886333007912), received between Oct 11, 2023 and Oct 11, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K160785); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Misassembled During Manufacturing /Shipping3

Patient problems

No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 11, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
WORKER GUIDEWIRE THE TIP OF THE WIRE IS NOT IN THE START POSITION, IT IS THE BACK OF THE WIRE THAT IS IN THE PURPLE CONNECTOR. THE CUSTOMER HAVE BEEN AWARE OF THIS, AFTER THEY HAVE SEEN SEVERAL CASES OF THAT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17913283 ↗
MalfunctionOct 11, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
THE WIRE HAS BEEN LOADED INTO THE CARRIER THE WRONG WAY AROUND, MEANING THE STIFFER END IS AT THE FRONT- SO IS PLACED INTO THE PATIENT FIRST RATHER THAN THE SOFT 3.5CM TIP END WHICH IS AT THE BACK. UPDATE WITH PER FORM: WORKER GUIDEWIRE. THE HARD/SHARP END OF THE WIRE IS IN THE START POSITION OF THE PRODUCT. SO IT IS PACKED WITH THE WRONG END OF WIRE IN THE START POSITION. BECAUSE OF BACK ORDERS WITH THIS ARTICLE THE CUSTOMER KEPT ONE BOX, AND MARKED THE BOX WITH WARNING! TURN DIRECTION. THEREFORE ONLY ONE BOX FOR INSPECTION BUT CREDIT 2 BOXES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17913232 ↗
MalfunctionOct 11, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
WORKER GUIDEWIRE IS PACKED WITH THE WRONG END AT THE START POSITION. A HUGE RISK BECAUSE THE END OF THE WIRE IS HARD/SHARP, BECAUSE OF BACKORDER OF THIS ARTICLE NUMBER, THE CUSTOMER CHOSE TO KEEP THE BOXES UNTIL A NEW DELIVERY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17912980 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160785. One submission often covers many models, so check the product and lot details in each record.

Z-1792-2020 · Dec 4, 2019 · Terminated
0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO
Z-1791-2020 · Dec 4, 2019 · Terminated
0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO

Device details

UDI-DI	`00886333007912`
Brand	Worker™ Guidewire
Model	110135080
Company	Argon Medical Devices, Inc.
Product code	DQX · Wire, Guide, Catheter
Class	Class 2
FDA submission	K160785
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	May 11, 2026

Device type (GMDN): Cardiac/peripheral vascular guidewire, single-use

A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

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All Wire, Guide, Catheter devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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