V. Mueller CH06162-2Recalls & reported problems

Steris Corporation · V. Mueller KNOT TIER/PUSHER 5MM SHAFT, ROUND SQUEEZE HANDLE WORKING LENGTH 10 inches 25CM OVERALL LENGTH 14.5 inches 36CM · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403181450), received between Dec 3, 2019 and Dec 3, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Physical Resistance/Sticking1

Patient problems

No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 3, 2019Physical Resistance/Sticking
CH06162-2 KNOT TIER/PUSHER - WOULD STICK SHUT DURING CASE. SEEM BETTER AFTER CLEANING/SONICING. THE SURGEON STATED THAT HE FELT THE PATIENT DID NOT DO AS WELL DUE TO THE PROBLEMS THAT OCCURRED WITH THE INSTRUMENTATION. THE SCHEDULED PROCEDURE WAS TO REPAIR THE VALVE. THE REPAIR DID NOT HOLD, SO TRIED TO REWORK THE RING, AND ENDED UP REPLACING THE VALVE. THE SURGEON STRUGGLE WITH THE OPENING AND CLOSING OF INSTRUMENTS THE ENTIRE CASE. THIS RESULTED IN THE PATIENT BEING UNDER ANESTHESIA FOR A PROLONGED PERIOD OF TIME AND POSSIBLY AN UNNECESSARY PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9406541 ↗

Device details

UDI-DI	`10885403181450`
Brand	V. Mueller
Model	CH06162-2
Catalog no.	CH061622
Company	Steris Corporation
Product code	HCF · INSTRUMENT, LIGATURE PASSING AND KNOT TYING
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 28, 2024

Device type (GMDN): Suture knot pusher, reusable

A hand-held manual surgical instrument that enables the user performing an internal suturing procedure (e.g., suturing a heart valve in the thoracic cavity) to advance suture knots created extracorporeally to the point of appropriate suture tension. It is a long, thin, rod-like device that has a guiding mechanism (e.g., an eyelet or groove) at its distal end, allowing it to be steered down one end of the suture as it pushes the knot with its blunted nose. Saline may be used to lubricate the suture and the knot pusher if necessary. This is a reusable device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.