27ga DEX™ Super Grip Forceps DVF4034-27Recalls & reported problems

Katalyst Surgical LLC · 27ga DEX™ Super Grip Forceps · Class 1

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10817489025557), received between Aug 6, 2026 and Aug 12, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

Mar 25, 2026Class IIOpen, Classified
Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.
Z-2080-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

Break1
Detachment of Device or Device Component1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229731 ↗
MalfunctionAug 6, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50168035 ↗

Device details

UDI-DI	`10817489025557`
Brand	27ga DEX™ Super Grip Forceps
Model	DVF4034-27
Company	Katalyst Surgical LLC
Product code	HNK · Probe, Trabeculotomy
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 2, 2025

Device type (GMDN): Ophthalmic soft-tissue manipulation forceps, probe-like, single-use

A sterile, hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small jaw-like grasping blades that protrude from the distal end of the shaft. This is a single-use device.

Other Probe, Trabeculotomy devices

25ga DEX™ Super Grip Forceps DVF4034-25
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1 recall0 reports
27ga DEX™ Morris ILM Forceps DVF4033-27
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3 reports

All Probe, Trabeculotomy 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 · each recall links to the FDA recall notice
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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