NA 0620030407Recalls & reported problems
Stryker Corporation · [High Flow Heated Insufflator Tubing, Do not use if package is damaged] · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327055627), received between Jun 19, 2018 and Jan 11, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 reports).
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
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material4
- Contamination /Decontamination Problem1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Known Impact Or Consequence To Patient5
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2024
INSUFFLATION TUBING CAME APART. POORLY SEALED, COULD NOT CONNECT TO TROCARS.
Patient problems: Insufficient Information
MAUDE report 18491052 ↗MalfunctionApr 10, 2019Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE OF THE STERILE PACKAGING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8499575 ↗MalfunctionJun 19, 2018Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE OF THE STERILE PACKAGING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7617469 ↗MalfunctionJun 19, 2018Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE OF THE STERILE PACKAGING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7617466 ↗MalfunctionJun 19, 2018Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE OF THE STERILE PACKAGING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7617343 ↗MalfunctionJun 19, 2018Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE OF THE STERILE PACKAGING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7617340 ↗
Other INSUFFLATOR, LAPAROSCOPIC devices
- HIGH FLOW INSUFFLATION UNIT UHI-3Olympus Medical Systems Corp. · INSUFFLATOR, LAPAROSCOPIC1 recall162 reports
- HIGH FLOW INSUFFLATION UNIT UHI-3Olympus Medical Systems Corp. · INSUFFLATOR, LAPAROSCOPIC1 recall48 reports
- AIRSEAL AS-iFS1Conmed Corporation · Insufflator, laparoscopic4 deaths93 reports
- Pneumosure 0620040610Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 death79 reports
- Pneumosure 0620040690Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 recall22 reports
- Pneumosure 0620040660Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 recall18 reports
- CYLINDER HOSE (PIN) FOR UHI-3 MAJ-1080Olympus Medical Systems Corp. · INSUFFLATOR, LAPAROSCOPIC58 reports
- STORZ 20400161SCanadian Hospital Specialties Limited · Insufflator, Laparoscopic1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.