Spacemaker SMSBTOVLXRecalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 10884521545311), received between Jan 30, 2017 and Aug 13, 2026 — classified as 9 injuries, 105 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (50 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 114 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Inflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240769 ↗
• MalfunctionFeb 4, 2026Inflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SETUP OF THE BALLOON TROCAR FOR A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE SURGEON PUT THE BALLOON INTO THE CAVITY, USER RELEASED THE BALLOON DID NOT EXPAND, THE SURGEON WANTED TO CONTROL THE BALLOON HE RELEASED THAT THE TIP OF THE NUMBER 2 TROCAR WAS BROKEN, THAT'S WHY THE BALLOON DID NOT EXPAND. THE ISSUE WAS RESOLVED BY OPENING A NEW DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257380 ↗
• MalfunctionAug 8, 2025Break; Gas/Air Leak; Break; Gas/Air Leak

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE FIRST DISSECTION BALLOON FUNCTIONED AS EXPECTED, WHILE THE SECOND ACCESS STRUCTURAL BALLOON APPEARED TO INSUFFLATE PROPERLY BUT SUBSEQUENTLY DISULFATED AT SOME POINT DURING THE PROCEDURE. THE BALLOON PHYSICALLY BROKE, WITH AN UNDETECTED BALLOON POP OR SLOW LEAK. THE SURGEON ONLY NOTICED THE ISSUE WHEN THE BALLOON WAS ALREADY WITHOUT AIR. THE SURGEON LEFT THE PRODUCT IN PLACE AND CONTINUED THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751084 ↗
• MalfunctionAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC REPAIR OF BILATERAL INGUINAL HERNIAS, THE DEVICE WAS ADVANCED INTO THE PERITONEUM WHILE BEING INSERTED INTO THE EXTRA-PERITONEAL SPACE, WHICH LED TO A CHANGE IN SURGICAL TECHNIQUE FROM TOTALLY EXTRAPERITONEAL (TEP) TO TRANSABDOMINAL PREPERITONEAL (TAPP) REPAIR. THE SURGERY WAS EXTENDED BY 15-20 MINUTES BUT WAS ABLE TO REMAIN LAPAROSCOPIC. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22746035 ↗
• MalfunctionAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC REPAIR OF BILATERAL INGUINAL HERNIAS, THE DEVICE WAS ADVANCED INTO THE PERITONEUM WHILE BEING INSERTED INTO THE EXTRA-PERITONEAL SPACE, WHICH LED TO A CHANGE IN SURGICAL TECHNIQUE FROM TOTALLY EXTRAPERITONEAL (TEP) TO TRANSABDOMINAL PREPERITONEAL (TAPP) REPAIR. THE SURGERY WAS EXTENDED BY 15-20 MINUTES BUT WAS ABLE TO REMAIN LAPAROSCOPIC. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22746029 ↗
• MalfunctionJun 13, 2025Inflation Problem; Leak/Splash; Material Split, Cut or Torn; Inflation Problem; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR TEP PROCEDURE, THE DEVICE EXPERIENCED SEVERAL PRODUCT ISSUES. THE VALVE SEAL DISENGAGED, THE BALLOON DID NOT INFLATE. THE VALVE SEAL WAS DAMAGED AND THE BALLOON LEAKED GAS OR AIR. ADDITIONAL MANUAL DISSECTION WAS PERFORMED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202576 ↗
• MalfunctionMay 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRA-PERITONEAL (TEP) INGUINAL HERNIA REPAIR PROCEDURE, WHILE ON THE START AT THE ACCESS STEP, THE SEAL DISENGAGED, CAUSING THE DISSECTION BALLOON TO NOT INFLATE. MANUAL DISSECTION WAS PERFORMED 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 22092851 ↗
• MalfunctionMar 13, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC TOTALLY EXTRAPERITONEAL HERNIA PROCEDURE, WHILE PUMPING UP, THE BALLOON DID NOT INFLATE. ANOTHER BALLOON WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21600412 ↗
• MalfunctionFeb 13, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRA-PERITONEAL BILATERAL HERNIA PROCEDURE, THE BALLOON DID NOT INFLATE DURING THE BALLOON INFLATION FOR DISSECTION STEP. THE BALLOON WAS REMOVED AND REPLACED WITH A KIDNEY DISSECTION BALLOON TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381238 ↗
• MalfunctionJan 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE SHEATH ON THE DISSECTION BALLOON DISENGAGED WHEN REMOVING THE DISSECTION BALLOON THROUGH THE TROCAR. THE DISSECTION BALLOON WAS REMOVED FROM THE PATIENT THROUGH THE STRUCTURAL TROCAR. THE SHEATH CAME OUT COMPLETELY IN ONE PIECE. NO FURTHER ACTION WAS REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219299 ↗
• MalfunctionDec 9, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR WITH MESH, THE SM PRO SMSBTOVLX ACCESS DISSECTOR SYSTEM EXPERIENCED A MALFUNCTION AS THE BALLOON DID NOT INFLATE. THERE WAS NO RAPID LOSS OF ABDOMINAL PRESSURE DUE TO THE DEVICE ISSUE. TO RESOLVE THE SITUATION AND COMPLETE THE CASE WITHOUT COMPLICATIONS, A NEW BALLOON KIT WAS OPENED. THERE WERE NO INJURIES, EXTENDED SURGICAL TIME, OR ADDITIONAL OPERATIONS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879082 ↗
• MalfunctionDec 6, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA REPAIR PROCEDURE, THE BALLOON EXPERIENCED AN ISSUE WHERE THE BLUE BULB WAS NOT WORKING AT THE BEGINNING OF THE PROCEDURE. THE DEVICE WOULD NOT INFLATE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20866004 ↗
• MalfunctionSep 13, 2024Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA REPAIR, THE BALLOON DID NOT INFLATE. A NEW DISSECTION BALLOON WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212672 ↗
• MalfunctionSep 5, 2024Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRA-PERITONEAL (TEP) INGUINAL HERNIA REPAIR, THE BALLOON WOULD NOT INFLATE AS AIR WAS LEAKING THROUGH THE BULB AS INFLATIONS OF THE DISSECTING BALLOON WAS ATTEMPTED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20151776 ↗
• MalfunctionSep 4, 2024

  BALLOON SYSTEM ITSELF AFTER INSERTION WOULD NOT INFLATE, WOULD NOT INFLATE FULLY IT WAS LOSING PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20133971 ↗
• MalfunctionAug 23, 2024Inflation Problem; Noise, Audible; Inflation Problem; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHILE BALLOON INFLATION, THE DEVICE MADE AN UNUSUAL NOISE, ALMOST A SQUEAKING TYPE. THE BALLOON ITSELF WOULD NOT INFLATE. THE ASSISTANT HAD THE CAMERA DOWN THE PORT AND NOTHING WAS HAPPENING. WHEN THE ASSISTANT BACKED THE CAMERA SLIGHTLY, THE BALLOON BEGAN TO INFLATE A LITTLE BIT. THE BALLOON EVENTUALLY DID INFLATE, HOWEVER, IT IT DID NOT APPEAR TO BE INFLATING AS QUICKLY OR AS IT NORMALLY WOULD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047904 ↗
• MalfunctionAug 14, 2024Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, AT THE BEGINNING OF THE PROCEDURE, WHEN THE DEVICE WAS INSERTED INTO THE INCISION BELOW THE BUTTON AND WAS ADVANCED INTO THE ABDOMINAL WALL, THE TWO BALLOONS DID NOT INFLATE WITH HAND-HELD BALLOON OR SYRINGE. ANOTHER DEVICE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982520 ↗
• MalfunctionAug 14, 2024Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, AT THE BEGINNING OF THE PROCEDURE, WHEN THE DEVICE WAS INSERTED INTO THE INCISION BELOW THE BUTTON AND WAS ADVANCED INTO THE ABDOMINAL WALL, THE TWO BALLOONS DID NOT INFLATE WITH HAND-HELD BALLOON OR SYRINGE. ANOTHER DEVICE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982280 ↗
• MalfunctionJul 26, 2024Inflation Problem; Difficult to Remove; Device Contamination with Chemical or Other Material; Inflation Problem; Difficult to Remove; Device Contamination with Chemical or Other Material

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE SCRUB TECHNICIAN WAS GETTING READY FOR SURGERY AND NOTICED THERE WAS AN EXTRA PIECE OF PLASTIC ATTACHED TO A FOAM SPONGE ON THE TROCAR THAT WAS NOT NORMALLY THERE. THE TROCAR WAS USED AS A FIRST INSERTION FOR THE SURGERY, AND THE SCRUB TECHNICIAN INFORMED THE SURGICAL ATTENDING OF THE DIFFERENCE BETWEEN THE TROCAR AND THE ATTENDING TESTED BALLOON AND NOTICED NOTHING WAS WRONG, THEN PROCEEDED TO DEFLATE THE BALLOONS AND REMOVED THE RANDOM PIECE OF PLASTIC. HOWEVER, WHEN THE BALLOON TROCAR WAS THEN INSERTED INTO THE PATIENT AND THE ATTENDING TRIED TO BLOW UP THE BALLOON AGAIN, THE BALLOON APPEARED TO NOT BE ABLE TO INFLATE, AS IF THERE WAS A HOLE, BUT THE TROCAR WAS STUCK AND EVENTUALLY GOT THE DEVICE OUT. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19837518 ↗
• MalfunctionJul 19, 2024Break; Inflation Problem; Detachment of Device or Device Component; Break; Inflation Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, AT THE TIME OF INFLATING THE DISSECTION BALLOON, THE VALVE DISENGAGED AND THE BALLOON DID NOT INFLATE. A NEW BALLOON WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19785991 ↗
• MalfunctionJul 15, 2024Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR, THE BALLOON DID NOT INFLATE. ANOTHER BALLOON WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19746344 ↗
• MalfunctionJul 15, 2024Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA REPAIR IN PRE-PERITONEAL SPACE, THE BALLOON DID NOT INFLATE. A NEW SPACEMAKER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744083 ↗
• MalfunctionJun 3, 2024Inflation Problem; Gas/Air Leak; Noise, Audible; Inflation Problem; Gas/Air Leak; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, UPON INFLATION OF THE DISSECTOR BALLOON, THE BALLOON LEAKED GAS THROUGH THE TROCAR. THE SURGEON CAN HEAR GAS LEAKING OUT, AND THEREFORE THE BALLOON DID NOT INFLATE FOR ADEQUATE DISSECTION. IT WAS NOTED THAT THE SURGERY TOOK MORE TIME TO DO MANUAL DISSECTION; IT WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448543 ↗
• MalfunctionMay 22, 2024Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) REPAIR, AT START OF PROCEDURE FOR DISSECTION OF SPACE, THE STRUCTURAL BALLOON DID NOT INFLATE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372879 ↗
• MalfunctionMay 17, 2024Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA REPAIR, DURING COMPONENT SEPARATION AT THE EXTRAPERITONEAL SPACE, THE BALLOON DID NOT INFLATE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341690 ↗