Spacemaker Plus SMSBTRNDRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521067837), received between Nov 2, 2017 and Dec 8, 2020 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2020Inflation Problem; Detachment of Device or Device Component; Inflation Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA REPAIR, BEFORE BALLOON INFLATION, THE WHITE CAP WAS NOT ATTACHED TO THE BODY OF THE DEVICE; HENCE, IT COULD NOT BE USED TO INFLATE BALLOON. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10964723 ↗
• MalfunctionDec 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA REPAIR, BEFORE BALLOON INFLATION, THE DISSECTION BALLOON WAS NOT ATTACHED TO THE BODY OF THE DEVICE. ANOTHER BALLOON WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10964704 ↗
• MalfunctionFeb 18, 2020Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, PREOPERATIVE FROM A LAPAROSCOPIC HERNIA SURGERY, THE TROCAR DID NOT FIT WELL IN THE CANNULA EVEN AFTER LUBRICATING IT SOMETIMES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9721498 ↗
• MalfunctionFeb 3, 2020Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, THE VALVE SEAL OF THE DEVICE WAS DAMAGED AND AIR KEPT LEAKING OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9659913 ↗
• MalfunctionDec 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE BALLOON DISENGAGED FROM THE TROCAR/ SLEEVE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9468628 ↗
• MalfunctionOct 7, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, PRIOR TO A TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA PROCEDURE, THE DEVICE'S OBTURATOR BROKE IN TRANSIT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9162916 ↗
• MalfunctionSep 23, 2019Break; Break

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

  Patient problems: No Patient Involvement

  MAUDE report 9107363 ↗
• MalfunctionJun 17, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL, WHEN INSERTING THE BALLOON INTO THE PREPERITONEAL TISSUE AND TRYING DO DILATE THE SPACE IN THE GROIN AREA, THE BALLOON DID 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 8704531 ↗
• MalfunctionNov 27, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHEN INSERTING THE BALLOON INTO THE PATIENT, IT WOULD NOT INFLATE IN THE PROPER MANNER. THE OBTURATOR BLADE WOULD NOT ENGAGE. THE BALLOON AND TROCAR WERE REPLACED AND PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8109216 ↗
• MalfunctionJul 18, 2018Inflation Problem

  ACCORDING TO THE REPORTER, THE BALLOON DID NOT INFLATE ON EXTRA-PERITONEAL SPACE ON A LAPAROSCOPIC LEFT INGUINAL HERNIA REPAIR. THEY OPENED UP A NEW SPACE MAKER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7698335 ↗
• MalfunctionApr 17, 2018Hole In Material; Inflation Problem; Gas/Air Leak; Hole In Material; Inflation Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE BALLOON DID NOT INFLATE. THE BALLOON HAD A LEAKAGE DUE TO A HOLE. A NEW UNIT WAS OPENED TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7436812 ↗
• MalfunctionMar 1, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TEP PROCEDURE, WHILE THE DEVICE WAS INSERTED INTO THE PRE-PERITONEAL SPACE TO PERFORM TEP, INGUINAL REGION, THE DEVICE¿S BALLOON DID NOT INFLATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7306962 ↗
• MalfunctionFeb 26, 2018Detachment Of Device Component; Inflation Problem; Detachment Of Device Component; Inflation Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA, THE BALLOON DID NOT INFLATE. THE PHYSICIAN FIRST OPENED THE OVAL BALLOON, DISSECTION BALLOON WOULD NOT INFLATE AND ALSO SMALL PIECE BROKE OFF AT THE ENTRY POINT OF SCOPE AND NOT IN PATIENT. THEY OPENED A ROUND BALLOON TO RESOLVE THE ISSUE HOWEVER, STILL IT DID NOT INFLATE EITHER. TO COMPLETE THE PROCEDURE, THEY MANUALLY DISSECTED IN THE PREPERITONEAL SPACE SINCE THE PREPERITONEAL BALLOON DID NOT INFLATE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7297160 ↗
• MalfunctionJan 9, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TOTALLY EXTRA-PERITONEAL INGUINAL HERNIA REPAIR, THE DEVICE¿S BALLOON DID NOT INFLATE WHILE BEING INSERTED AND APPLIED ON EXTRATERRITORIAL SPACE. NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7176706 ↗
• MalfunctionDec 21, 2017Break; Gas/Air Leak; Break; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A TOTALLY EXTRAPERITONEAL LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE UNIT PHYSICALLY BROKE AND HAD A GAS OR AIR LEAKED. WHEN THE DEVICE WAS INSERTED TO THE PATIENT, THE PHYSICIAN NOTICED THAT THE BALLOON WAS ON ABNORMAL CONDITION. THE BALLOON COULD NOT CONTAIN AIR AND WHEN THE PHYSICIAN TOOK OUT THE DEVICE THEY FOUND A TEAR IN THE MIDDLE OF THE BALLOON. THEY USED A NEW DEVICE TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7141170 ↗
• MalfunctionDec 5, 2017Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TEP HERNIA REPAIR PROCEDURE, THE DEVICE DID NOT INFLATE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY HAS BEEN NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7082751 ↗
• MalfunctionNov 2, 2017Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, INTRA OPERATIVELY IN A LAP HERNIA PROCEDURE, THE DEVICE WOULD NOT HOLD PRESSURE AND IT WOULD NOT INFLATE. THERE WAS NO PATIENT INJURY. A NEW DEVICE WAS USED TO RESOLVE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6995878 ↗