Spacemaker SMSBTRNDXRecalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 10884521545328), received between Jun 5, 2017 and Jun 23, 2025 — classified as 1 injury, 73 malfunctions.

The most frequently reported specific device problem is “Break” (40 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 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Break; Decrease in Pressure; Break; Decrease in Pressure

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) PROCEDURE FOR MESH IMPLANTATION, AT THE END OF THE PROCEDURE , THERE WAS A HOLE IN THE BALLOON, WHICH RESULTED IN A RAPID LOSS OF ABDOMINAL PRESSURE DUE TO LOSS OF PNEUMOPERITONEUM. TO RESOLVE THE SITUATION AND COMPLETE THE CASE, INSUFFLATION WAS TRANSFERRED TO A DIFFERENT TROCAR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310561 ↗
• MalfunctionMar 19, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE DISSECTION BALLOON WOULD NOT INFLATE WHEN INITIALLY INSERTED FOR DISSECTION OF THE INGUINAL SPACE. TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE, A NEW ROUND DISSECTION BALLOON OF THE SAME TYPE WAS OPENED AND WORKED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649205 ↗
• MalfunctionJul 25, 2024Break; Inflation Problem; Break; Inflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19830930 ↗
• MalfunctionJul 15, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  PRODUCT WAS RECEIVED WITHOUT ACCOMPANYING INFORMATION. MEDTRONIC'S INITIAL EVALUATION OF THE RETURNED PRODUCT FOUND THE DISSECTOR BALLOON HAD A HOLE AT THE DISTAL END WITH THE LONG OBTURATOR INSERTED.

  Patient problems: Insufficient Information

  MAUDE report 19741503 ↗
• MalfunctionJun 28, 2024Break; Leak/Splash; Break; Leak/Splash

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE BALLOON HAD A HOLE AND DEFLATED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19635387 ↗
• MalfunctionJun 19, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, AT THE TIME OF DISSECTION, THE DISSECTION BALLOON LEAKED AIR AND DID NOT INFLATE. THE ISSUE OCCURRED IN FIVE DEVICES. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571071 ↗
• MalfunctionJun 19, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, AT THE TIME OF DISSECTION, THE DISSECTION BALLOON LEAKED AIR AND DID NOT INFLATE. THE ISSUE OCCURRED IN FIVE DEVICES. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571069 ↗
• MalfunctionJun 19, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, AT THE TIME OF DISSECTION, THE DISSECTION BALLOON LEAKED AIR AND DID NOT INFLATE. THE ISSUE OCCURRED IN FIVE DEVICES. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571067 ↗
• MalfunctionJun 17, 2024Break; Inflation Problem; Break; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THERE WAS A HOLE IN THE BALLOON AND DID NOT INFLATE, THE BALLOON BROKE DURING THE DISSECTION FOR THE REPAIR OF THE INGUINAL WALL. THE SURGERY CONTINUED WITHOUT THE DISSECTOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554732 ↗
• MalfunctionJun 17, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, AT THE TIME OF DISSECTION, THE DISSECTION BALLOON LEAKED AIR AND DID NOT INFLATE. THE ISSUE OCCURRED IN FIVE DEVICES. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554443 ↗
• MalfunctionJun 17, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, AT THE TIME OF DISSECTION, THE DISSECTION BALLOON LEAKED AIR AND DID NOT INFLATE. THE ISSUE OCCURRED IN FIVE DEVICES. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554420 ↗
• MalfunctionJun 6, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, ON DISSECTION, THE BALLOON POPPED AND WAS DEFLATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477141 ↗
• MalfunctionMay 24, 2024Break; Inflation Problem; Break; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, ON TISSUE DISSECTION, THE BALLOON PHYSICALLY BROKE AND DID NOT INFLATE. ANOTHER BALLOON KIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393554 ↗
• MalfunctionMay 20, 2024Break; Gas/Air Leak; Break; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, IN INFLATION OF THE DISSECTION BALLOON, THE BALLOON LEAKED GAS OR AIR. ADDITIONALLY, AFTER EIGHT VERY SLOW PUMPS, THE BALLOON POPPED. TO RESOLVE THE ISSUE, A BLUNT DISSECTION DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355325 ↗
• MalfunctionMay 9, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHEN THE DISSECTION BALLOON WAS INSULATED, 15 PUMPS WERE MADE EVERY FIVE SECONDS, THUS VERY SLOWLY. WHEN DONE, THE BALLOON WAS KEPT INFLATED FOR ONE MINUTE FOR THE TAMPONADE EFFECT. DURING THIS TIME, THE BALLOONS POPPED WITHOUT ANY INSULATION. NOTHING DISSECTION WAS DONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279523 ↗
• MalfunctionApr 10, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, THE DISSECTION BALLOON POPPED AFTER 15 VERY SLOW PUMPS. A SCOPE DISSECTION WAS DONE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19082170 ↗
• MalfunctionApr 10, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, THE BALLOON POPPED AFTER 16 SLOW PUMPS DURING INSUFFLATION OF THE SPACEMAKER. A NEW SPACEMAKER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19078386 ↗
• MalfunctionApr 5, 2024Break; Gas/Air Leak; Break; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, AT THE TIME OF INSUFFLATION OF THE DISSECTION BALLOON, THE DISSECTION BALLOON POPPED AFTER 8 PUMPS. IT WAS NOTED THAT THE BALLOON ALSO LEAKED GAS OR AIR. A BLUNT DISSECTION WITH SCOPE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055654 ↗
• MalfunctionApr 5, 2024Inflation Problem; Leak/Splash; Detachment of Device or Device Component; Inflation Problem; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, IN THE INSULATION OF THE DISSECTION BALLOON, THE VALVE SEAL DISLODGED FROM THE PORT. THE BALLOON DID NOT INFLATE, IT WAS LEAKING GAS OR AIR. TO RESOLVE THE ISSUE, A BLUNT DISSECTION DEVICE WITH SCOPE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055106 ↗
• MalfunctionMar 18, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) INGUINAL HERNIA PROCEDURE, WHEN THE DEVICE WAS PUMPED, THE BALLOON BURST. IT WAS NOTED THAT THERE WAS A HOLE IN THE BALLOON. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18926866 ↗
• MalfunctionNov 30, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, AFTER ONLY A FEW PUMPS, DISSECTION BALLOON POPPED (PHYSICALLY BROKEN). ANOTHER DEVICE WAS USED RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241594 ↗
• MalfunctionSep 13, 2023Break; Noise, Audible; Break; Noise, Audible

  ACCORDING TO THE REPORTER, LAPAROSCOPIC HERNIA REPAIR PROCEDURE, WHEN THE SURGEON ATTEMPTED TO USE THE DEVICE, BALLOON BROKE AND MADE A ¿POP¿ SOUND. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17740786 ↗
• MalfunctionAug 30, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA SURGERY, AT INFLATION OF DISSECTION BALLOON, BALLOON POPPED AFTER ONLY FIVE PUMPS. ANOTHER BALLOON WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17654859 ↗
• MalfunctionAug 9, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, THE ISSUE OCCURRED DURING THE DISSECTION OF THE PRE-PERITONEAL SPACE WHEN THE DEVICE BEING APPLIED, SPECIFICALLY THE BALLOON USED TO ASSIST IN THE DISSECTION, PHYSICALLY BROKE. TO RESOLVE THE ISSUE AND COMPLETE THE CASE, A NEW BALLOON WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17490794 ↗
• InjuryJul 11, 2023Inflation Problem; Product Quality Problem; Inflation Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, TWO DAYS POST OPERATIVE OF A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) UNILATERAL INGUINAL HERNIA REPAIR, WHERE THE DEVICE PROVIDED INADEQUATE DISSECTION AS COMPARED TO ANOTHER BALLOON DURING THE CASE, IN PARTICULAR LATERAL DISSECTION THAT REQUIRED THE SURGEON TO MANUALLY DISSECT THE SPACE, AND THE PROCEDURE BEING CONVERTED FROM LAPAROSCOPIC TO OPEN DUE TO DIFFICULTIES IN THE CASE, THE PATIENT WAS BROUGHT TO THE EMERGENCY DEPARTMENT AFTER COLLAPSING AND NOT FEELING WELL. THE EMERGENCY DEPARTMENT COMPLETED RELEVANT TEST AND IDENTIFIED THAT THE PATIENT HAD BLEEDING OF MORE THAN 1 LITER FROM THE PROCEDURE. THE EMERGENCY DEPARTMENT EMBOLIZED THE BLEEDING USING MEDICAL THERAPY. THE PATIENT WAS ADMITTED IN THE INTENSIVE CARE UNIT (ICU). IT WAS STATED THAT DURING THE PROCEDURE, THE DISSECTION BALLOON HAD A DIFFERENT PLACEMENT ON THE OBTURATOR AND THE OBTURATOR WAS A DIFFERENT SHAPE/LENGTH. IT WAS STATED THAT THE PATIENT ISSUES WERE PRECIPITATED BY THE DEVICE ISSUE. THE PATIENT IS CURRENTLY MEDICALLY STABLE AND IN HOSPI TAL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Syncope/Fainting; Unspecified Tissue Injury

  MAUDE report 17302378 ↗