PDB OMS-PDB1000Recalls & reported problems
Covidien LP · Round Shape Balloon · Class 2
Quick summary
This Covidien round balloon is a surgical balloon used in hernia repair surgery. Most of the 859 reports describe balloons that could not be inflated, often because they had broken or developed a hole, and in several cases surgeons switched to another balloon to continue. The reports include 4 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
- 859
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 859 adverse event reports that list this exact device (DI 10884521067929), received between Dec 13, 2016 and Sep 29, 2026 — classified as 4 injuries, 855 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (571 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
- Inflation Problem571
- Break429
- Gas/Air Leak37
- Material Split, Cut or Torn34
- Detachment of Device or Device Component31
- Leak/Splash24
- Noise, Audible14
- Detachment Of Device Component10
Patient problems
- No Clinical Signs, Symptoms or Conditions562
- No Known Impact Or Consequence To Patient169
- No Consequences Or Impact To Patient108
- Insufficient Information24
- No Patient Involvement10
- No Information5
- Foreign Body In Patient3
- No Code Available2
Recent adverse event reports
The 25 most recent of 859 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935670 ↗MalfunctionSep 29, 2026Break; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935648 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926358 ↗MalfunctionSep 21, 2026Inflation Problem; Gas/Air Leak
It was reported that during a TEP (totally extraperitoneal) hernioplasty, the balloon did not inflate and leaked gas/air. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839509 ↗MalfunctionSep 17, 2026Break; Inflation Problem
It was reported that during a TEP hernioplasty, the balloon did not inflate. Upon examination, it was observed that the balloon had a hole and was physically broken. Their was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802549 ↗MalfunctionSep 15, 2026Inflation Problem
According to the reporter during the totally extraperitoneal hernioplasty, balloon did not inflate. A new balloon was used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766588 ↗MalfunctionSep 15, 2026Break
According to the reporter, during the laparoscopic totally extraperitoneal hernia repair, the device was being used in the preperitoneal space when the balloon physically broke and deflated. The balloon ruptured after approximately 5 to 10 inflations. It was removed without difficulty and replaced with a new balloon, which functioned normally and allowed the procedure to be completed. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766509 ↗MalfunctionAug 11, 2026Break; Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216962 ↗MalfunctionAug 10, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50194058 ↗MalfunctionAug 5, 2026Break; Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50138614 ↗MalfunctionAug 4, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50131739 ↗MalfunctionJul 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50065754 ↗MalfunctionJul 29, 2026Break; Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50065642 ↗MalfunctionJul 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50061043 ↗MalfunctionJul 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50059717 ↗MalfunctionJun 24, 2026Inflation Problem
ACCORDING TO THE REPORTER, DURING PRE-OPERATIVE PREPARATION FOR A TEP (TOTALLY EXTRAPERITONEAL) HERNIOPLASTY, THE BALLOON WAS TESTED AND COULD NOT BE INFLATED. A NEW BALLOON WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25605075 ↗MalfunctionJun 9, 2026Inflation Problem
IT WAS REPORTED THAT DURING THE TOTALLY EXTRAPERITONEAL HERNIOPLASTY FOR COLON CANCER, THE BALLOON COULD NOT BE INFLATED. A NEW BALLOON WAS USED TO CONTINUE THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25451474 ↗MalfunctionMay 1, 2026Inflation Problem
ACCORDING TO THE REPORTER, DURING A TOTALLY EXTRAPERITONEAL HERNIOPLASTY PROCEDURE, THE BALLOON COULD NOT BE INFLATED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055832 ↗MalfunctionApr 27, 2026Break
IT WAS REPORTED THAT PREOPERATIVELY, THE BALLOON ROUND SHAPE WAS UNUSABLE BECAUSE THE BALLOON PART BURST AND THERE WAS A HOLE IN THE BALLOON. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25001028 ↗MalfunctionApr 21, 2026Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) HERNIA PROCEDURE USING A ROUND SHAPE BALLOON, THE SURGEON NOTICED THAT THE BALLOON HAD RUPTURED WHILE BEING INFLATED AND THAT THE BALLOON PHYSICALLY BROKE. THE BALLOON WAS REMOVED AND THE OPERATION CONTINUED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24948663 ↗MalfunctionApr 21, 2026Inflation Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHEN A ROUND SHAPE BALLOON WAS INSERTED AND, AT COMMENCEMENT OF INFLATION, THE BALLOON DID NOT INFLATE. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24935142 ↗MalfunctionApr 14, 2026Break
IT WAS REPORTED THAT PREOPERATIVELY OF A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE BALLOON THAT WAS DEPLOYED RUPTURED AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873343 ↗MalfunctionApr 12, 2026Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE BUT PRIOR TO PATIENT USE, THE BALLOON TROCAR THAT WAS DEPLOYED RUPTURED AND COULD NOT BE USED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853238 ↗MalfunctionApr 9, 2026Break; Inflation Problem
IT WAS REPORTED THAT DURING A TOTALLY EXTRAPERITONEAL (TEP) HERNIOPLASTY, THE BALLOON RUPTURED AND COULD NOT BE INFLATED. THE OPERAT OR USED A NEW BALLOON TO CONTINUE THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831558 ↗MalfunctionApr 7, 2026Break
IT WAS REPORTED THAT PREOPERATIVELY, THE BALLOON PORTION OF THE TROCAR RUPTURED, AND DID NOT INFLATE. THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24797325 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.