AeroStat® C1002Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607915116682), received between Mar 9, 2017 and Mar 13, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2025Unintended Movement; Unintended Movement

  PROCEDURE PERFORMED: PERCUTANEOUS CHOLANGIOGRAPHY CATHETER WI. EVENT DESCRIPTION: DURING THE DEPLOYMENT OF THE RETENTION CONE IN THE CYSTIC DUCT, A BREAK IN CONTINUITY OF THE POSTERIOR WALL OF THE CYSTIC DUCT IS EVIDENT, CAUSED BY THE RETENTION CONE. WIDE DISSECTION OF THE CYSTIC DUCT WAS REQUIRED UNTIL ITS INSERTION INTO THE BILIARY TRACT. CHOLANGIOGRAPHY COULD NOT BE PERFORMED. ADDITIONAL INFORMATION PROVIDED ON 19FEB2025 BY EMAIL: THE ENTIRE CONE WAS INSERTED INTO THE DUCT. YES, THE CONE WAS EXPANDED. YES, IT WAS FULLY EXPANDED. NO INFORMATION ON THE SIZE OF THE DUCT. YES, IT WAS DIFFICULT TO OPEN/CLOSE. PATIENT STATUS: THE PROCEDURE COULD NOT BE COMPLETED. INTERVENTION: CHOLANGIOGRAPHY COULD NOT BE PERFORMED.

  Patient problems: Perforation

  MAUDE report 21599736 ↗
• MalfunctionNov 4, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  PROCEDURE PERFORMED: [LAP CHOLECYSTECTOMY] EVENT DESCRIPTION: HOSPITAL: [HOSPITAL NAME] THE EVENT DATE IS UNKNOWN. DUE TO THESE ISSUES, (NAME REDACTED) HAS SWITCHED TO THE UROTECH UROLOGY CATHETER OF 5 FR (1.67MM), 70 CM LENGTH. HE NOTED THE UROTECH CATHETER IS CHEAPER AND MORE CONVENIENT FOR HIM. HE INTRODUCES IT VIA A REUSABLE INTRODUCER FROM A DIFFERENT BRAND AND SECURES IT WITH A CHOLANGIOGRAM CLIP. HE EXPRESSED THAT HE WILL NO LONGER BE USING OUR CATHETER. DESPITE HIS CONCERNS, (NAME REDACTED) WAS SATISFIED WITH OUR VISIT AND ALLOWED US TO ATTEND A SURGERY TO OBSERVE OUR CATHETER IN USE. DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, WE WITNESSED THE DIFFICULTIES FIRSTHAND. THE PATIENT HAD A THIN AND SMALL CYSTIC DUCT, AND THE C1002 CATHETER EXPERIENCED RESISTANCE, PREVENTING INSERTION AND NECESSITATING ADDITIONAL FORCE, WHICH COULD POTENTIALLY DAMAGE THE CYSTIC DUCT OR EVEN PERFORATE IT (WHAT HAS HAPPENED TO HIM BEFORE). (NAME REDACTED) CONTINUED THE PROCEDURE WITH THE UROTECH CATHETER, WHICH HE WAS ABLE TO INSERT DUE TO ITS SMALLER DIAMETER (1.67MM). OUR CATHETER¿S DIAMETER RANGES FROM 2-6.7MM. IT IS ALSO WORTH MENTIONING THAT (NAME REDACTED) , ANOTHER SURGEON AT THE SAME HOSPITAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605577 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: [LAP CHOLECYSTECTOMY] EVENT DESCRIPTION: HOSPITAL: [HOSPITAL NAME] [PENETRATION OF THE CYSTIC DUCT TO PERFORM A CHOLANGIOGRAPHY. ACUTE CHOLECYSTITIS -> CYSTIC TEAR AND POSTERIOR CYSTIC PERFORATION. NEED TO RECLIP LOWER AND CLOSER TO THE COMMON BILE DUCT. RISK OF POST-OP BILE LEAKAGE. RECLIP LOWER AND CLOSER TO THE COMMON BILE DUCT AND CONTACT DRAINAGE WAS NECESSARY. NO ADDITIONAL HEALTH IMPACTS FOR NOW. ADDITIONAL INFORMATION RECEIVED BY COMPANY REP. VIA TEAMS ON 22AUG24: ACCORDING TO THE PHARMACIST, THE SURGEON HAD DIFFICULTY INSERTING THE END OF THE CATHETER INTO THE CYSTIC DUCT AS THE DUCT WAS TOO SMALL IN DIAMETER, SO IT PERFORATED. I HAVE TRIED CONTACTING THE SURGEON, TO GET AN APPOINTMENT AND MAYBE ATTEND A SURGERY ACCOMPANIED BY SOMEONE FROM CD] TYPE OF INTERVENTION: [RECLIP LOWER AND CLOSER TO THE COMMON BILE DUCT AND CONTACT DRAINAGE WAS NECESSARY] PATIENT STATUS: [PATIENT IS STABLE AND NO PROLONGED HOSPITAL STAY].

  Patient problems: Perforation

  MAUDE report 20140400 ↗
• MalfunctionMar 9, 2017Disconnection; Disconnection

  PROCEDURE PERFORMED UNKNOWN - "DURING USE THE DEVICE DISMANTLED IN THE MIDDLE WHICH CREATED SOME DIFFICULTIES TO HANDLE IT. IT WAS IMPOSSIBLE TO RECONNECT THE 2 PIECES OF THE HANDLE." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6391439 ↗