Spacemaker SMCYLCSTRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521545335), received between Aug 6, 2017 and Dec 5, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO THE START OF A LAPAROSCOPIC PROCEDURE, WHEN THE PACKAGING OF THE DEVICE WAS OPENED, THE CONNECTION PART OF THE STEM WAS FOUND TO BE BROKEN. TO RESOLVE THE ISSUE, ANOTHER DEVICE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23725282 ↗
• MalfunctionAug 21, 2023Break; Difficult to Insert; Break; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, PRIOR TO INSERTING THE PATIENT, THE SPACER BALLOON OBTURATOR WOULD NOT INSERT INTO THE TROCAR CANNULA AND THE BALLOON TORE WHILE TRYING TO FORCE THE OBTURATOR INTO THE CANNULA. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17592126 ↗
• MalfunctionApr 12, 2023Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN OPENING THE PRODUCT, IT WAS FOUND THAT THE BALLOON WAS TORN. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724640 ↗
• MalfunctionMar 10, 2023Decrease in Pressure; Gas/Air Leak; Decrease in Pressure; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC PROSTATECTOMY INTO THE ABDOMINAL CAVITY, THE BALLOON DEFLATE. THERE WAS A RAPID LOSS OF ABDOMINAL PRESSURE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522378 ↗
• MalfunctionOct 3, 2022Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC PROSTATOVESICULECTOMY, THE BALLOON DID NOT INFLATE. THE SURGEON OPTED FOR ANOTHER SURGICAL TECHNIQUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15529350 ↗
• MalfunctionAug 16, 2021Break; Break

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC PROCEDURE, THE DEVICE WAS ONLY SAVED FOR RETURN AND MARKED AS BROKEN. TO FIX THE ISSUE, A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324120 ↗
• MalfunctionMay 13, 2021Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COMPONENT SEPARATION, WHEN THE BALLOON WAS INSERTED BETWEEN INTERNUS AND EXTERNUS MUSCLE SPACE, THE DEVICE WOULD NOT INFLATE AND LEAKED OUT AIR THROUGH THE TROCAR. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816159 ↗
• MalfunctionOct 23, 2020Break; Leak/Splash; Decrease in Pressure; Break; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC INCISIONAL HERNIA SURGERY, WHEN INFLATING THE BALLOON, IT WAS PUNCTURED NOT HOLDING THE PNEUMOPERITONEUM BUT THE SURGERY CONTINUED WITH THE BALLOON LEAKING AIR. RAPID LOSS OF ABDOMINAL PRESSURE WAS OBSERVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10725691 ↗
• MalfunctionSep 20, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC, ENDOSCOPIC COMPONENT SEPARATION, WHEN THE BALLOON WAS PLACED TO CREATE THE SPACE BETWEEN THE EXTERNUS AND INTERNUS APONEUROSIS, THE BALLOON DID NOT INFLATE. ANOTHER DEVICE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7893446 ↗
• MalfunctionAug 6, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC COMPONENT SEPARATION PROCEDURE. DURING THE PLACEMENT OF THE BALLOON AND THE REMOVAL OF THE OBTURATOR TO PLACE THE SCOPE, THE PLASTIC TOP OF THE OBTURATOR BROKE OFF. THERE WAS ENOUGH OBTURATOR LEFT EXPOSED TO GRAB IT WITH HAND AND REMOVE IT. THERE WAS NO RAPID LOSS OF ABDOMINAL PRESSURE DUE TO THE DEVICE ISSUE. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6769938 ↗