M-Close Kit 27-101Recalls & reported problems
New Wave Endo-Surgery Inc. · The device is a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall which is non-powered, hand-held, and hand-manipulated, intended to be used in various general surgical procedures. The device includes a ligature carrier pathway, needle guide, two needles, reference plane T-Bar, and a guidewire. The handle of the device provides two diametrically opposed enclosed guideways for the advancement and retraction of the needles under manual control of a plunger located at the proximal end of the device.As part of the M-Close convenience kit, Nerve Block Needles are included for the administration of local anesthetic agents to provide regional and local anesthesia. · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850009417022), received between Aug 14, 2023 and Feb 25, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (1 report).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Jul 8, 2020Terminated
The plastic housing on the device may fracture
Z-1570-2023 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Activation Failure1
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.
MalfunctionFeb 25, 2026
WHILE USING THE M-CLOSE DEVICE, IT WAS NOTICED THAT PART OF IT, SPECIFICALLY THE LOOP WIRE, WAS MISSING. CT AND X-RAY WERE COMPLETED ON THE PATIENT, NEGATIVE FOR FOREIGN BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24442245 ↗MalfunctionAug 15, 2025Activation Failure
THE DEVICE WOULD NOT COMPLETE THE SECOND CLICK TO COMPLETE THE CLOSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22814542 ↗MalfunctionAug 14, 2023
M-CLOSE DEVICE NOT FIRING PROPERLY WHEN INSERTED INTO PATIENT. SURGEON INSERTED M-CLOSE DEVICE, ATTEMPTED TO DEPLOY, HOWEVER M-CLOSE DEVICE WAS DEFECTIVE. NO HARM DONE TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17540044 ↗
Other Instrument, Ligature Passing And Knot Tying devices
- IDEAL 251005Medos International Sàrl · INSTRUMENT, LIGATURE PASSING AND KNOT TYING99 reports
- IDEAL 251003Medos International Sàrl · INSTRUMENT, LIGATURE PASSING AND KNOT TYING87 reports
- OverStitch Endoscopic Suturing System ESS-G02-160Apollo Endosurgery, Inc. · Instrument, Ligature Passing And Knot Tying4 deaths76 reports
- AESCULAP MB362RAesculap, Inc. · INSTRUMENT, LIGATURE PASSING AND KNOT TYING1 recall0 reports
- AESCULAP MB215RAesculap, Inc. · INSTRUMENT, LIGATURE PASSING AND KNOT TYING1 recall0 reports
- OverStitch Endoscopic Suturing System CNH-G01-000Apollo Endosurgery, Inc. · Instrument, Ligature Passing And Knot Tying48 reports
- IDEAL 251004Medos International Sàrl · INSTRUMENT, LIGATURE PASSING AND KNOT TYING42 reports
- OverStitch Endoscopic Suturing System Sx ESS-G02-Sx1Apollo Endosurgery, Inc. · Instrument, Ligature Passing And Knot Tying38 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.