Spacemaker SMBTTRNDXRecalls & reported problems
Covidien LP · Access and Dissector System · Class 2
Quick summary
This Covidien Spacemaker access and dissector system uses balloons to separate tissue during laparoscopic surgery. Most of the 579 reports describe parts breaking, balloons failing to inflate properly, or pieces detaching, and a few mention plastic fragments falling into the patient. The reports include 9 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 590
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 590 adverse event reports that list this exact device (DI 10884521545304), received between Sep 2, 2016 and Sep 30, 2026 — classified as 9 injuries, 581 malfunctions.
The most frequently reported specific device problem is “Break” (325 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.
Reports received per month
Most reported problems
Device problems
- Break325
- Inflation Problem178
- Detachment of Device or Device Component87
- Packaging Problem44
- Leak/Splash32
- Gas/Air Leak25
- Material Split, Cut or Torn25
- Adverse Event Without Identified Device or Use Problem15
Patient problems
- No Clinical Signs, Symptoms or Conditions399
- No Consequences Or Impact To Patient68
- No Known Impact Or Consequence To Patient66
- Insufficient Information58
- No Patient Involvement12
- Unspecified Tissue Injury7
- Hemorrhage/Blood Loss/Bleeding5
- No Information4
Recent adverse event reports
The 25 most recent of 590 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 50952399 ↗MalfunctionSep 30, 2026Inflation Problem
It was reported during a laparoscopic procedure that two balloons did not inflate. A new product was used to resolve the issue. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947179 ↗MalfunctionSep 30, 2026Inflation Problem
It was reported during a laparoscopic procedure that two balloons did not inflate. A new product was used to resolve the issue. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946724 ↗MalfunctionSep 24, 2026Break
According to the reporter, intra-operatively of a laparoscopic inguinal hernia repair, during dissection, two balloons physically ruptured. Another device was used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876990 ↗MalfunctionSep 24, 2026Break
According to the reporter, intra-operatively of a laparoscopic inguinal hernia repair, during dissection, two balloons physically ruptured. Another device was used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876983 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846974 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846972 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846834 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843081 ↗MalfunctionSep 21, 2026Break
According to the reporter, during a laparoscopic surgery, the balloon burst and could not be inflated. A new device was used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842769 ↗MalfunctionSep 16, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796534 ↗MalfunctionSep 16, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788479 ↗MalfunctionSep 15, 2026Inflation Problem
According to the reporter, pre-operatively, the balloon did not inflate. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50769832 ↗MalfunctionAug 26, 2026Break; Detachment of Device or Device Component; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459850 ↗MalfunctionAug 26, 2026Break; Detachment of Device or Device Component; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459701 ↗MalfunctionAug 26, 2026Break; Detachment of Device or Device Component; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459542 ↗MalfunctionAug 26, 2026Inflation Problem
Patient problems: Insufficient Information
MAUDE report 50456926 ↗MalfunctionAug 26, 2026Detachment of Device or Device Component; Scratched Material
It was reported that during a laparoscopic inguinal total extraperitoneal (TEP) procedure, the two dissecting balloons were inflated during dissection, and the balloons ruptured. Dissection could not be performed with the original balloon, and plastic balloon frag ments fell into the patient cavity. An inspection was performed to remove the plastic fragments. It was also mentioned that the balloon that needed to inflate had a dull color. Surgical time was extended by 30 minutes or more. To resolve the issue, dissection was completed with another balloon until adequate space was created.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50455666 ↗MalfunctionAug 26, 2026Detachment of Device or Device Component; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50455569 ↗MalfunctionAug 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50312255 ↗MalfunctionAug 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211742 ↗MalfunctionAug 11, 2026Break; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209849 ↗MalfunctionAug 7, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50169771 ↗MalfunctionAug 7, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50169759 ↗MalfunctionAug 7, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50168878 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.