Insufflation Needle C2201Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00607915116767), received between Feb 23, 2021 and Sep 10, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (2 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722362 ↗
• MalfunctionMay 14, 2026Fail-Safe Did Not Operate

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: THE VERESS NEEDLE WAS BEING USED FOR INSUFFLATION. THE ISSUE OCCURRED DURING THE INSERTION OF THE NEEDLE. AT THAT TIME, THE NEEDLE PERFORATED THE LIVER. ACCORDING TO THE USER, NO ¿CLICK¿ WAS PERCEIVED WHEN THE VERESS NEEDLE PASSED THROUGH THE ABDOMINAL WALL (PERITONEUM). AS A RESULT, THE NEEDLE WAS INSERTED TOO DEEPLY, WHICH MAY HAVE LED TO THE LIVER PERFORATION. THE USER ALSO REPORTED THAT THE NEEDLE DID NOT GLIDE SMOOTHLY DURING INSERTION. NO INTERNAL COMPLAINT WAS FILED BY THE CUSTOMER REGARDING THIS INCIDENT. HOWEVER, THIS INFORMATION IS BEING REPORTED AS IT WAS CONSIDERED RELEVANT TO DOCUMENT THE EVENT. THE INFORMATION WAS RELAYED INDIRECTLY VIA THE HOSPITAL PHARMACIST, WHO REQUESTED THE RETURN OF THE REMAINING STOCK (VERESS NEEDLES, REFERENCE (B)(4). AT THIS STAGE, IT REMAINS UNCLEAR WHETHER THE ISSUE IS DEVICE-RELATED OR ASSOCIATED WITH THE USE OF THE DEVICE, WHICH MAY DIFFER FROM THE TECHNIQUE APPLIED WITH THE PRODUCT PREVIOUSLY USED BY THE SURGEON. ACCORDING TO THE HEAD NURSE, A USE-RELATED ISSUE IS CONSIDERED MORE LIKELY. THE EVENT WAS REPORTED AS A PRECAUTION, AS IT OCCURRED TWICE [NEW COMPLAINT CREATED], IN ORDER TO ASSESS WHE

  Patient problems: Liver Laceration(s)

  MAUDE report 25174684 ↗
• MalfunctionMay 14, 2026Fail-Safe Did Not Operate

  PROCEDURE PERFORMED: NI EVENT DESCRIPTION: THE VERESS NEEDLE WAS BEING USED FOR INSUFFLATION. THE ISSUE OCCURRED DURING THE INSERTION OF THE NEEDLE. AT THAT TIME, THE NEEDLE PERFORATED THE LIVER. ACCORDING TO THE USER, NO ¿CLICK¿ WAS PERCEIVED WHEN THE VERESS NEEDLE PASSED THROUGH THE ABDOMINAL WALL (PERITONEUM). AS A RESULT, THE NEEDLE WAS INSERTED TOO DEEPLY, WHICH MAY HAVE LED TO THE LIVER PERFORATION. THE USER ALSO REPORTED THAT THE NEEDLE DID NOT GLIDE SMOOTHLY DURING INSERTION. NO INTERNAL COMPLAINT WAS FILED BY THE CUSTOMER REGARDING THIS INCIDENT. HOWEVER, THIS INFORMATION IS BEING REPORTED AS IT WAS CONSIDERED RELEVANT TO DOCUMENT THE EVENT. THE INFORMATION WAS RELAYED INDIRECTLY VIA THE HOSPITAL PHARMACIST, WHO REQUESTED THE RETURN OF THE REMAINING STOCK (VERESS NEEDLES, REFERENCE C2201). AT THIS STAGE, IT REMAINS UNCLEAR WHETHER THE ISSUE IS DEVICE-RELATED OR ASSOCIATED WITH THE USE OF THE DEVICE, WHICH MAY DIFFER FROM THE TECHNIQUE APPLIED WITH THE PRODUCT PREVIOUSLY USED BY THE SURGEON. ACCORDING TO THE HEAD NURSE, A USE-RELATED ISSUE IS CONSIDERED MORE LIKELY. THE EVENT WAS REPORTED AS A PRECAUTION, AS IT OCCURRED TWICE [NEW COMPLAINT CREATED], IN ORDER TO ASSESS WHET

  Patient problems: Liver Laceration(s)

  MAUDE report 25174626 ↗
• MalfunctionOct 13, 2023Dull, Blunt; Dull, Blunt

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY EVENT DESCRIPTION: TWO INSUFFLATION NEEDLE COMPLAINTS OCCURRED AT [FACILITY]. COMPLAINT 1 OF 2: (B)(4) - C2201 LOT #1495499. COMPLAINT 2 OF 2: (B)(4) - C2201 LOT# UNKNOWN. THE SURGEON NOTED THAT THE NEEDLE WAS DULLER THAN USUAL AND IT WAS DIFFICULT TO INSERT THE NEEDLE. THE STYLET WAS ABLE TO BE RETRACTED. THE SURGEON HAS EXPERIENCED THIS MULTIPLE TIMES OVER THE PAST WEEK. NO OTHER INSTRUMENTS WERE BEING USED AT THE TIME OF THE EVENT. NO PATIENT INJURY OCCURRED. THE CASE WAS COMPLETED USING THE SAME DEVICE. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 03OCT2023 FROM ACCOUNT MANAGER II, APPLIED MEDICAL. "THEY MENTIONED THAT THIS HAD HAPPENED A FEW TIMES OVER THE PRIOR WEEK BUT DID NOT KNOW THE CASE DATES/TIMES ETC. NO PATIENTS HAVE BEEN HURT AND THE SURGEON USED THE NEEDLE AS INTENDED EACH TIME, NOTING THAT IT FELT HARDER TO PENETRATE THE PERITONEUM. I HAVE ASKED FOR MORE INFORMATION BUT THIS IS ALL I HAVE BEEN ABLE TO GATHER. SEVERAL OTHERS USE THE VERESS NEEDLE AND NO ONE ELSE HAS COMPLAINED OR HAD AN ISSUE." COMPLAINT (B)(4) WAS CREATED TO ACCOUNT FOR ALL THE OTHER INSTANCES THAT OCCURRED IN TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936176 ↗
• MalfunctionSep 29, 2023Dull, Blunt; Material Twisted/Bent; Dull, Blunt; Material Twisted/Bent

  PROCEDURE PERFORMED: LAVH EVENT DESCRIPTION: THE REP WAS NOT PRESENT FOR THE CASE BUT TALKED TO AN ER TECH WHO WAS IN THE CASE. WAS TOLD THAT WHEN THE DEVICE WAS INITIALLY INSERTED, THE TIP OF THE NEEDLE HIT HARD TISSUE AND BENT. THE DEVICE WAS REMOVED AND ABOUT LESS THAN A QUARTER INCH OF THE TIP OF THE NEEDLE WAS BENT. THE CASE WAS COMPLETE WITH A NEW INSUFFLATION NEEDLE WITHOUT ISSUE. THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE. PRODUCT IS AVAILABLE FOR RETURN INTERVENTION: THE CASE WAS COMPLETED WITH A NEW ONE PATIENT STATUS: PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844855 ↗
• MalfunctionFeb 23, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  PROCEDURE PERFORMED: LAPAROSCOPIC INGUINAL HERNIA REPAIR. THE ACCOUNT MGR WAS NOT PRESENT FOR THE CASE. THE INSUFFLATION NEEDLE WAS ATTACHED TO THE INSUFFLATION TUBING. DR [NAME] COULDN'T GET ANY INSUFFLATION AFTER INSERTING THE NEEDLE. WHEN TRYING TO REMOVE THE INSERT, PULLED OUT THE ENTIRE NEEDLE. IT IS UNKNOWN IF THERE WAS ANY NOTICEABLE LEAKAGE. OPENED A NEW INSUFFLATION NEEDED AND CONTINUED THE CASE WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR RETURN. INTERVENTION: OPENED A NEW INSUFFLATION NEEDLE TO COMPLETE THE CASE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369406 ↗