Spacemaker SMBTTOVLXRecalls & reported problems

Summary

The FDA's MAUDE database contains 422 adverse event reports that list this exact device (DI 10884521545298), received between Jul 19, 2016 and Sep 30, 2026 — classified as 14 injuries, 408 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (187 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 422 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955101 ↗
• MalfunctionSep 30, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951279 ↗
• MalfunctionAug 4, 2026Break; Inflation Problem; Decrease in Pressure; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131244 ↗
• MalfunctionAug 4, 2026Break; Inflation Problem; Decrease in Pressure; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131208 ↗
• MalfunctionAug 4, 2026Break; Inflation Problem; Decrease in Pressure; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131184 ↗
• InjuryAug 3, 2026Leak/Splash; Adverse Event Without Identified Device or Use Problem

  It was reported that during a laparoscopic inguinal hernia repair, the balloon port repeatedly shifted position and the balloon leaked gas/air, resulting in gas leakage from the body and difficulty continuing the laparoscopic procedure. The case was converted from laparoscopic to open surgery to complete the procedure. Blood loss of 500 cc or more was reported due to the product issue, and no blood transfusion was required.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 50111796 ↗
• MalfunctionJun 25, 2026Break; Inflation Problem; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) PROCEDURE, DURING INFLATION WHILE CREATING THE PREPERITONEAL SPACE IN THE LOWER ABDOMINAL EXTRAPERITONEAL TISSUE PRIOR TO MESH PLACEMENT, THE TWO BALLOON-TIP TROCARS WERE RUPTURED. MOREOVER, ANOTHER TWO BALLOON TROCARS WITH DIFFERENT LOT NUMBERS HAD A HOLE, AND THE BALLOON DID NOT INFLATE, AND THERE WAS A RAPID LOSS OF PRESSURE. THE DEVICE WAS REPLACED WITH ANOTHER BRAND TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630918 ↗
• MalfunctionJun 25, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) PROCEDURE, DURING INFLATION WHILE CREATING THE PREPERITONEAL SPACE IN THE LOWER ABDOMINAL EXTRAPERITONEAL TISSUE PRIOR TO MESH PLACEMENT, THE TWO BALLOON-TIP TROCARS WERE RUPTURED. MOREOVER, ANOTHER TWO BALLOON TROCARS WITH DIFFERENT LOT NUMBERS HAD A HOLE, AND THE BALLOON DID NOT INFLATE, AND THERE WAS A RAPID LOSS OF PRESSURE. THE DEVICE WAS REPLACED WITH ANOTHER BRAND TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630916 ↗
• MalfunctionJun 25, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) PROCEDURE, DURING INFLATION WHILE CREATING THE PREPERITONEAL SPACE IN THE LOWER ABDOMINAL EXTRAPERITONEAL TISSUE PRIOR TO MESH PLACEMENT, THE TWO BALLOON-TIP TROCARS WERE RUPTURED. MOREOVER, ANOTHER TWO BALLOON TROCARS WITH DIFFERENT LOT NUMBERS HAD A HOLE, AND THE BALLOON DID NOT INFLATE, AND THERE WAS A RAPID LOSS OF PRESSURE. THE DEVICE WAS REPLACED WITH ANOTHER BRAND TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630887 ↗
• MalfunctionJun 23, 2026Break; Inflation Problem; Decrease in Pressure; Gas/Air Leak

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEPP), AFTER A WORKING SPACE WAS CREATED BETWEEN THE ABDOMINAL MUSCLES AND THE PERITONEUM, THREE FIXATION BALLOONS AT THE TROCAR TIP WERE FOUND RUPTURED WITH A HOLE AND FAILED TO INFLATE PROPERLY DUE TO LEAKAGE. TO COMPLETE THE OPERATION, THE DEFECTIVE TROCAR WAS REPLACED WITH AN ALTERNATIVE BALLOON-TIP TROCAR FROM ANOTHER MANUFACTURER TO STABILIZE THE SPACE AND AVOID GAS LEAKAGE. THERE WAS RAPID LOSS OF ABDOMINAL PRESSURE DUE TO THE DEVICE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602937 ↗
• MalfunctionJun 10, 2026Break; Inflation Problem; Detachment of Device or Device Component; Gas/Air Leak

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEPP) PROCEDURE, THE THREE UNITS OF TROCAR TIP BALLOON DID NOT INFLATE, WAS RUPTURED, AND WAS NOT STABLE, HENCE THE LEAKAGE. THE ISSUE ALSO CAUSED A RAPID LOSS OF ABDOMINAL PRESSURE. ANOTHER BRAND TROCAR WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456820 ↗
• MalfunctionJun 10, 2026Break; Inflation Problem; Detachment of Device or Device Component; Gas/Air Leak

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEPP) PROCEDURE, THE THREE UNITS OF TROCAR TIP BALLOON DID NOT INFLATE, WAS RUPTURED, AND WAS NOT STABLE, HENCE THE LEAKAGE. THE ISSUE ALSO CAUSED A RAPID LOSS OF ABDOMINAL PRESSURE. ANOTHER BRAND TROCAR WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456773 ↗
• MalfunctionJun 1, 2026Break; Inflation Problem

  IT WAS REPORTED THAT DURING A TOTALLY EXTRAPERITONEAL (TEP) PROCEDURE, THE BALLOON FAILED TO INFLATE AND APPEARED TO BE RUPTURED DURING ATTEMPTED INFLATION. ADDITIONAL UNITS FROM OTHER BOXES WERE OPENED, AND THE SAME ISSUE OCCURRED REPEATEDLY WITH A TOTAL OF THREE DEVICES. THE SURGICAL TEAM CONVERTED TO ANOTHER TROCAR FROM ANOTHER MANUFACTURER TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25353163 ↗
• MalfunctionJun 1, 2026Break; Inflation Problem

  IT WAS REPORTED THAT DURING A TOTALLY EXTRAPERITONEAL (TEP) PROCEDURE, THE BALLOON FAILED TO INFLATE AND APPEARED TO BE RUPTURED DURING ATTEMPTED INFLATION. ADDITIONAL UNITS FROM OTHER BOXES WERE OPENED, AND THE SAME ISSUE OCCURRED REPEATEDLY WITH A TOTAL OF THREE DEVICES. THE SURGICAL TEAM CONVERTED TO ANOTHER TROCAR FROM ANOTHER MANUFACTURER TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25353137 ↗
• MalfunctionJun 1, 2026Break; Inflation Problem

  IT WAS REPORTED THAT DURING A TOTALLY EXTRAPERITONEAL (TEP) PROCEDURE, THE BALLOON FAILED TO INFLATE AND APPEARED TO BE RUPTURED DURING ATTEMPTED INFLATION. ADDITIONAL UNITS FROM OTHER BOXES WERE OPENED, AND THE SAME ISSUE OCCURRED REPEATEDLY WITH A TOTAL OF THREE DEVICES. THE SURGICAL TEAM CONVERTED TO ANOTHER TROCAR FROM ANOTHER MANUFACTURER TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25353113 ↗
• MalfunctionMay 26, 2026Break; Inflation Problem; Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT DURING AN OPEN TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA PROCEDURE, THE ACCESS BALLOON WAS FOUND TO BE RUPTURED AND DID NOT INFLATE. THE TROCAR REPORTEDLY WOULD NOT STAY PROPERLY IN PLACE DUE TO LACK OF BALLOON TIP STABILITY, AND GAS LEAKAGE OCCURRED THROUGHOUT THE PROCEDURE WITH RAPID LOSS OF ABDOMINAL PRESSURE. IT OCCURRED ON FOUR DEVICES. THE DEVICE WAS REPLACED BY OPENING AND USING ANOTHER BRAND TROCAR TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25292421 ↗
• MalfunctionMay 26, 2026Break; Inflation Problem; Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT DURING AN OPEN TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA PROCEDURE, THE ACCESS BALLOON WAS FOUND TO BE RUPTURED AND DID NOT INFLATE. THE TROCAR REPORTEDLY WOULD NOT STAY PROPERLY IN PLACE DUE TO LACK OF BALLOON TIP STABILITY, AND GAS LEAKAGE OCCURRED THROUGHOUT THE PROCEDURE WITH RAPID LOSS OF ABDOMINAL PRESSURE. IT OCCURRED ON FOUR DEVICES. THE DEVICE WAS REPLACED BY OPENING AND USING ANOTHER BRAND TROCAR TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25291773 ↗
• MalfunctionMay 26, 2026Break; Inflation Problem; Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT DURING AN OPEN TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA PROCEDURE, THE ACCESS BALLOON WAS FOUND TO BE RUPTURED AND DID NOT INFLATE. THE TROCAR REPORTEDLY WOULD NOT STAY PROPERLY IN PLACE DUE TO LACK OF BALLOON TIP STABILITY, AND GAS LEAKAGE OCCURRED THROUGHOUT THE PROCEDURE WITH RAPID LOSS OF ABDOMINAL PRESSURE. IT OCCURRED ON FOUR DEVICES. THE DEVICE WAS REPLACED BY OPENING AND USING ANOTHER BRAND TROCAR TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25291690 ↗
• MalfunctionMay 13, 2026Break; Inflation Problem; Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA REPAIR, AFTER A SMALL INFRAUMBILICAL INCISION WAS MADE AND THE BALLOON DISSECTOR WAS INSERTED TO SECURE THE TROCAR, THE BALLOON RUPTURED DURING INFLATION. ANOTHER KIT WAS OPENED AND THE BALLOON AGAIN RUPTURED, AND THIS OCCURRED IN THREE KITS. THE BALLOON DID NOT INFLATE, LEAKED GAS, AND THERE WAS RAPID LOSS OF ABDOMINAL PRESSURE. TO COMPLETE THE PROCEDURE, ANOTHER KIT WAS OPENED AND THEN A TROCAR FROM ANOTHER BRAND WAS USED. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY, AND NO MEDICAL OR SURGICAL INTERVENTION, HOSPITALIZATION, OR ADDITIONAL OPERATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157579 ↗
• MalfunctionMay 13, 2026Break; Inflation Problem; Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA REPAIR, AFTER A SMALL INFRAUMBILICAL INCISION WAS MADE AND THE BALLOON DISSECTOR WAS INSERTED TO SECURE THE TROCAR, THE BALLOON RUPTURED DURING INFLATION. ANOTHER KIT WAS OPENED AND THE BALLOON AGAIN RUPTURED, AND THIS OCCURRED IN THREE KITS. THE BALLOON DID NOT INFLATE, LEAKED GAS, AND THERE WAS RAPID LOSS OF ABDOMINAL PRESSURE. TO COMPLETE THE PROCEDURE, ANOTHER KIT WAS OPENED AND THEN A TROCAR FROM ANOTHER BRAND WAS USED. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY, AND NO MEDICAL OR SURGICAL INTERVENTION, HOSPITALIZATION, OR ADDITIONAL OPERATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157554 ↗
• MalfunctionMay 13, 2026Break; Inflation Problem; Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA REPAIR, AFTER A SMALL INFRAUMBILICAL INCISION WAS MADE AND THE BALLOON DISSECTOR WAS INSERTED TO SECURE THE TROCAR, THE BALLOON RUPTURED DURING INFLATION. ANOTHER KIT WAS OPENED AND THE BALLOON AGAIN RUPTURED, AND THIS OCCURRED IN THREE KITS. THE BALLOON DID NOT INFLATE, LEAKED GAS, AND THERE WAS RAPID LOSS OF ABDOMINAL PRESSURE. TO COMPLETE THE PROCEDURE, ANOTHER KIT WAS OPENED AND THEN A TROCAR FROM ANOTHER BRAND WAS USED. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY, AND NO MEDICAL OR SURGICAL INTERVENTION, HOSPITALIZATION, OR ADDITIONAL OPERATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157549 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC TOTAL EXTRAPERITONEAL INGUINAL HERNIA REPAIR, THE BALLOON DEVELOPED A HOLE DURING BALLOON INFLATION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034675 ↗
• MalfunctionApr 13, 2026Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRA-PERITONEAL (TEP) INGUINAL HERNIA REPAIR, THE TWO BALLOON DID NOT INFLATE. THE SURGEON USED OTHER MEANS TO MAKE THE SPACE. THE SURGICAL TIME WAS EXTENDED BY 20 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858253 ↗
• MalfunctionApr 13, 2026Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRA-PERITONEAL (TEP) INGUINAL HERNIA REPAIR, THE TWO BALLOON DID NOT INFLATE. THE SURGEON USED OTHER MEANS TO MAKE THE SPACE. THE SURGICAL TIME WAS EXTENDED BY 20 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858236 ↗
• MalfunctionMar 19, 2026Inflation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA PROCEDURE, SPECIFICALLY DURING THE DISSECTION OF SPACE, THE BALLOON DID NOT INFLATE. THE ISSUE WAS RESOLVED BY OPENING ANOTHER DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638305 ↗