PDB OMS-PDBS2Recalls & reported problems
Covidien LP · Kidney Shape Balloon · Class 2
All models of PDB (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien Kidney Shape Balloon is a balloon used to create working space during laparoscopic surgery. Its 254 reports often describe the balloon failing to inflate or parts detaching, and some mention parts falling into the patient, while some reports say a replacement device was used to finish the procedure. The reports include 10 injuries and no deaths. Reports dropped from 24 in the previous 12 months to 4 in the most recent 12 months. 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
- 255
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 255 adverse event reports that list this exact device (DI 10884521067943), received between Nov 7, 2016 and Sep 16, 2026 — classified as 10 injuries, 245 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (121 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component121
- Inflation Problem87
- Break44
- Detachment Of Device Component11
- Difficult to Remove8
- Difficult to Insert5
- Gas/Air Leak5
- Insufficient Device Problem Information5
Patient problems
- No Clinical Signs, Symptoms or Conditions146
- No Consequences Or Impact To Patient38
- No Known Impact Or Consequence To Patient34
- Insufficient Information26
- No Code Available8
- No Information4
- Tissue Damage3
- Foreign Body In Patient2
Recent adverse event reports
The 25 most recent of 255 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Difficult to Insert; Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794327 ↗MalfunctionAug 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311665 ↗MalfunctionJul 28, 2026Inflation Problem; Component Missing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50061738 ↗MalfunctionDec 16, 2025Inflation Problem; Inflation Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY, WHILE ON RETROPERITONEAL INFLATION, THE BALLOON DID NOT INFLATE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23821422 ↗MalfunctionNov 17, 2025Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY, WHEN LEAVING SPACE IN THE RETROPERITONEAL SPACE, THE BALLOON DID NOT INFLATE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23576396 ↗MalfunctionJul 28, 2025Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY, THE BALLOON DID NOT INFLATE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22631372 ↗MalfunctionJul 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEPP) INGUINAL HERNIA REPAIR, THE TROCAR WAS BEING INFLATED AND THE KIDNEY SHAPED DISSECTION BALLOON COMPONENT FELL INTO THE PATIENT AND WAS SUBSEQUENTLY RETRIEVED. ANOTHER TROCAR WAS OPENED 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 22555436 ↗MalfunctionJun 7, 2025Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove
ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC UROLOGICAL SURGERY , WHEN THE CAMERA WAS INSERTED INTO THE BALLOON, A SLIGHT RESISTANCE WAS FELT, BUT AS THE CAMERA ADVANCED AS IT WAS, THE CAMERA BECAME STUCK AND COULD NOT BE REMOVED. ANOTHER CAMERA AND BALLOON WERE USED TO RESOLVE THE ISSUE AND COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22163452 ↗MalfunctionJun 6, 2025Inflation Problem; Inflation Problem
IT WAS REPORTED THAT DURING A TOTALLY EXTRAPERITONEAL (TEP) HERNIA LAPAROSCOPIC PROCEDURE, THE DEVICE DID NOT INFLATE DURING BALLOON DISSECTION. THE ISSUE WAS RESOLVED BY USING ANOTHER BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22159068 ↗MalfunctionJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE BALLOON GOT SEPARATED FROM THE TROCAR WHEN REMOVING IT FROM THE PATIENT. THE TWO BALLOON PIECES NEEDED TO BE REMOVED MANUALLY WITH A CLAMP. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22133932 ↗MalfunctionMay 27, 2025Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RETROPERITONEAL DETACHMENT WITH ROBOT SUPPORT, WHEN PERFORMING BALLOON PUMPING, THE BALLOON DID NOT INFLATE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22093121 ↗MalfunctionMay 22, 2025Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY, DURING DISLODGEMENT OF THE RETROPERITONEAL CAVITY, 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 22071334 ↗MalfunctionApr 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP), DURING BALLOON INSERTION, THE KIDNEY BALLOON DISENGAGED FROM THE TROCAR. THE BALLOON FELL INTO THE CAVITY. THE BALLOON WAS REMOVED WITH A LAPAROSCOPIC GRASPER. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21880708 ↗MalfunctionApr 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER AFTER USING THE BALLOON DURING SURGERY, THE INSTRUMENT WAS REMOVED. THE VINYL AND THE INSTRUMENT CAME OUT SEPARATELY, SO THE DOCTOR PULLED IT OUT THROUGH ANOTHER INSTRUMENT. SURGERY TIME WAS EXTENDED.
Patient problems: Insufficient Information
MAUDE report 21762547 ↗MalfunctionMar 28, 2025Decrease in Pressure; Detachment of Device or Device Component; Decrease in Pressure; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC KIDNEY EXPLANT, THE BALLOON DETACHED FROM THE DISSECTOR CANNULA DURING INSUFFLATION FOR RETROPERITONEAL AERATION. IT WAS NOTED THAT THE ISSUE CAUSED A SUDDEN DECREASE IN ABDOMINAL PRESSURE. A NEW DEVICE WAS USED TO RESOLVE THE PROBLEM.
Patient problems: Unspecified Tissue Injury
MAUDE report 21727090 ↗MalfunctionFeb 25, 2025Break; Break
IT WAS REPORTED THAT THE TWO PDB BALLOONS EXPLODED. A NEW BALLOON WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 21458164 ↗MalfunctionFeb 21, 2025Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY, AT THE TIME OF INFLATING THE RETROPERITONEUM, DURING A BALLOON INFLATION, AIR LEAKED, AND THE BALLOON DID NOT INFLATE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21434942 ↗MalfunctionFeb 19, 2025Inflation Problem; Material Split, Cut or Torn; Inflation Problem; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY, WHEN PERFORMING A RETROPERITONEAL DISSECTION, THE SEAL AT THE PORT INSERTION SITE WAS DAMAGED AND THE BALLOON'S INFLATED STATE COULD NOT BE MAINTAINED DUE TO THE DAMAGE FOR BOTH DEVICE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 21410218 ↗MalfunctionFeb 19, 2025Inflation Problem; Material Split, Cut or Torn; Inflation Problem; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY, WHEN PERFORMING A RETROPERITONEAL DISSECTION, THE SEAL AT THE PORT INSERTION SITE WAS DAMAGED AND THE BALLOON'S INFLATED STATE COULD NOT BE MAINTAINED DUE TO THE DAMAGE FOR BOTH DEVICE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 21410124 ↗MalfunctionFeb 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC KIDNEY TRANSPLANT PROCEDURE, THE BALLOON WAS DISCONNECTED FROM THE CANNULA WHEN AIR WAS DELIVERED SEVERAL TIMES (4-5 TIMES) TO INFLATE THE RETROPERITONEAL SPACE. THE DEVICE WAS MANUALLY EXPLANTED USING FORCEPS. TO RESOLVE THE ISSUE, THE RETROPERITONEAL DILATATION WAS PERFORMED AGAIN USING ANOTHER BALLOON. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21355841 ↗MalfunctionJan 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A KIDNEY-SHAPED BALLOON FELL APART IN A PATIENT DURING A PROCEDURE. THE BALLOON WAS RETRIEVED COMPLETELY WITH A KELLY CLAMP AND TACTILE FEEL THROUGH THE INFRAUMBILICAL FASCIAL INCISION. ONCE THE BALLOON WAS RETRIEVED, THE SURGICAL TEAM WAS ABLE TO INSUFFLATE THE PREPERITONEAL SPACE AND CONTINUE THE CASE. THERE WAS NO INJURY REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21126375 ↗MalfunctionJan 3, 2025Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, ON THREE DEVICES, THE BALLOON DID NOT INFLATE. IT DID NOT HOLD AIR.
Patient problems: Insufficient Information
MAUDE report 21072182 ↗MalfunctionJan 3, 2025Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, ON THREE DEVICES, THE BALLOON DID NOT INFLATE. IT DID NOT HOLD AIR.
Patient problems: Insufficient Information
MAUDE report 21072145 ↗MalfunctionJan 3, 2025Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, ON THREE DEVICES, THE BALLOON DID NOT INFLATE. IT DID NOT HOLD AIR. PRODUCT RECEIVED WITHOUT ACCOMPANYING INFORMATION.
Patient problems: Insufficient Information
MAUDE report 21072075 ↗MalfunctionNov 15, 2024Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC TOTALLY EXTRAPERITONEAL HERNIA REPAIR, THE AIR WAS LET OUT WHEN PULLING OUT THE TROCAR. IT WAS NOTED THAT THE BALLOON DETACHED FROM THE TROCAR AND TORE. THE INSTRUMENT WAS NO LONGER NEEDED AFTERWARDS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20695037 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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