Spacemaker Plus SMBTTOVLRecalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 10884521067417), received between Sep 6, 2016 and Jun 30, 2022 — classified as 2 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (55 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 25 most recent of 112 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2022Inflation Problem; Decrease in Pressure; Gas/Air Leak; Inflation Problem; Decrease in Pressure; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR BY TOTAL EXTRA PERITONEAL TECHNIQUE, AT MOMENT TO INFLATE THE BALLOON, THE DEVICE DID NOT INFLATE. THE BALLOON LEAKED GAS/AIR. THERE WAS A RAPID LOSS OF ABDOMINAL PRESSURE NOTED. THE OPERATOR USED ANOTHER DEVICE OF THE SAME LOT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880813 ↗
• MalfunctionJan 20, 2022Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, WHEN INSERTING THROUGH TROCAR AND INFLATION OF THE DISSECTING BALLOON, THE DEVICE DID NOT INFLATE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306509 ↗
• MalfunctionJun 3, 2021Break; Leak/Splash; Break; Leak/Splash

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROSTATECTOMY, THE BALLOON BURST AND CAUSED CARBON DIOXIDE LEAKAGE THROUGH THE TROCAR. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11934712 ↗
• MalfunctionApr 12, 2021Break; Break

  ACCORDING TO THE REPORTER, THE BALLOON WAS PHYSICALLY BROKEN PRIOR TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648178 ↗
• MalfunctionFeb 11, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BALLOON PHYSICALLY BROKE.

  Patient problems: Insufficient Information

  MAUDE report 11313859 ↗
• MalfunctionFeb 11, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BALLOON PHYSICALLY BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11313227 ↗
• MalfunctionDec 28, 2020Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE SEAL WAS DAMAGED AND LEAKS FROM THE VALVE WERE NOTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11076459 ↗
• MalfunctionNov 9, 2020Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  ACCORDING TO THE REPORTER, ON A BILATERAL INGUINAL REPAIR, THE VALVE SEAL WAS DAMAGED AND THERE WAS LEAKING. THE USER CHANGED TO ANOTHER ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10809314 ↗
• MalfunctionNov 5, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRA-PERITONEAL (TEP) INGUINAL HERNIA PROCEDURE, THE TWO DEVICES COULD NOT MAINTAIN ABDOMINAL PRESSURE, AND THE SEALS OF THE DEVICES WERE DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10789994 ↗
• MalfunctionNov 4, 2020Break; Break

  ACCORDING TO THE REPORTER, THERE WAS A PERFORATION ON THE BALLOON DURING THE PASSAGE OF THE TRANSCUTANEOUS NEEDLE.

  Patient problems: No Information

  MAUDE report 10785097 ↗
• MalfunctionNov 3, 2020Inflation Problem; Material Split, Cut or Torn; Inflation Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING PROCEDURE, AFTER INSERTING THE BALLOON INTO THE ABDOMEN, THE BALLOON DID NOT INFLATE BECAUSE IT WAS PUNCTURED.

  Patient problems: No Information

  MAUDE report 10778970 ↗
• MalfunctionNov 3, 2020Break; Break

  ACCORDING TO THE REPORTER, THE DISSECTOR HAD BROKEN VALVE SO DEVICE COULD NOT BE USED.

  Patient problems: No Information

  MAUDE report 10777030 ↗
• MalfunctionOct 24, 2020Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE BALLOON BURST. IT WAS NOT POSSIBLE TO BE INFLATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10731691 ↗
• MalfunctionOct 2, 2020Break; Inflation Problem; Break; Inflation Problem

  ACCORDING TO THE REPORTER, IN THE BEGINNING WHEN THE SURGEON WAS TRYING TO EXPAND THE BALLOON DISSECTOR ON A LAPAROSCOPIC LEFT INGUINAL HERNIA REPAIR, THE BALLOON WOULD NOT INFLATE DUE VALVE SEAL DAMAGE. SURGEON OPENED ANOTHER DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10622147 ↗
• MalfunctionOct 1, 2020Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, DURING INSERTION OF THE TROCAR, THE BALLOON DEFLATED AND THERE WAS AIR OR GAS LEAK. IT WAS REPORTED THAT THE TROCAR WAS UNABLE TO STABILIZE IT AND HAD THE BALLOON RE-INFLATED TO FIX THE TROCAR. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10613350 ↗
• MalfunctionSep 28, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING INFLATION OF THE BALLOON ON A LAPAROSCOPIC HERNIA REPAIR, THE BALLOON PHYSICALLY BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10597441 ↗
• MalfunctionSep 2, 2020Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA REPAIR, WHEN INSUFFLATING THE BALLOON, THE BALLOON AND SPACE WILL NOT STAY INSUFFLATED. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10482966 ↗
• MalfunctionAug 25, 2020Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE BALLOON WOULD NOT INFLATE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10451550 ↗
• MalfunctionJul 16, 2020Inflation Problem; Decrease in Pressure; Inflation Problem; Decrease in Pressure

  ACCORDING TO THE REPORTER. DURING BILATERAL INGUINAL HERNIA REPAIR, DURING INSERTING THE DISSECTION BALLOON TO CREATE THE PREPERITONEUM SPACE, THE DISSECTION BALLOON DID NOT INFLATE. IT WAS NOTED THAT THERE WAS RAPID LOSS OF ABDOMINAL PRESSURE. SURGEON USED BLUNT DISSECTION METHOD TO CREATE THE PREPERITONEUM SPACE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286133 ↗
• MalfunctionJul 10, 2020Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE BALLOON DID NOT INFLATE SO THE DISSECTION WAS NOT POSSIBLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10257527 ↗
• MalfunctionJul 8, 2020Break; Gas/Air Leak; Break; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA REPAIR, IT WAS NOTED THAT THE SEAL OF THE DEVICE BROKE THAT CAUSED BALLOON AIR LEAK. ANOTHER OF THE SAME DEVICE WAS OPENED AND USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10244610 ↗
• MalfunctionJul 7, 2020Inflation Problem; Packaging Problem; Inflation Problem; Packaging Problem

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR, THE SEAL WAS CRACKED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE BALLOON DID NOT INFLATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 10241098 ↗
• MalfunctionJul 7, 2020Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, WHILE LOADING THE CAMERA PORT PART OF THE DEVICE, THE BALLOON INFLATED BY ONE SIDE AND COULD NOT BE LOADED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10239153 ↗
• MalfunctionJun 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TOTALLY EXTRAPERITONEAL HERNIA REPAIR, THE DEVICE WOULD NOT HOLD A SEAL. THE NEW PRODUCT WAS PULLED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10203292 ↗
• MalfunctionMar 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING APPLIED TO THE LOWER ABDOMEN DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL INGUINAL HERNIA REPAIR, THERE WAS AN INCONSISTENT INSUFFLATION PRESSURE AND FLOW AT THE START OF THE PROCEDURE. THE SURGEON NOTICED THAT THE VALVE SEAL HAD DISENGAGED AND WAS STUCK INSIDE THE TROCAR CANNULA. THE CANNULA WAS REMOVED FROM THE PATIENT AND INSERTED A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9835649 ↗