Wayne G56535Recalls & reported problems
Cook Incorporated · Wayne Pneumothorax Set · Class 2
Quick summary
This Cook Wayne Pneumothorax Set is a suction catheter set used to drain air from around the lung. The 50 reports mostly describe the tubing coming apart or unravelling, leaking, and breaking, and sometimes being hard to remove; a few mention a chest drain valve separating at its joint during a thoracostomy procedure. Seven reports involve injuries and no deaths are described. 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
- 50
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00827002565357), received between Dec 20, 2016 and Aug 14, 2026 — classified as 7 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (20 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
- Unraveled Material20
- Leak/Splash11
- Break8
- Difficult to Remove7
- Material Separation6
- Use of Device Problem3
- Deformation Due to Compressive Stress2
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Insufficient Information7
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient5
- Pneumothorax3
- Foreign Body In Patient2
- No Patient Involvement2
- Pain2
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2026Use of Device Problem
It was reported that the obturator included in the Wayne Pneumothorax Set was inadvertently left in the catheter following placement into the patient and attachment to the Under Water Seal Drain (UWSD).The obturator used during placement of the pigtail catheter over the wire guide was erroneously left inside the catheter. The catheter was then attached to UWSD via extension tubing. The drain was then observed to be swinging and bubbling whilst in the Emergency Department (ED). The patient was then moved to the inpatient ward and had multiple reviews for subcutaneous emphysema and a significant increase in pain, in which the patient required analgesia. The straightener was removed 24 hours post insertion.
Patient problems: Pain
MAUDE report 50261016 ↗MalfunctionJul 29, 2026Unraveled Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071801 ↗MalfunctionDec 15, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23803774 ↗MalfunctionDec 9, 2025Break; Unraveled Material; Break; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23757138 ↗MalfunctionSep 12, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23042706 ↗MalfunctionAug 25, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22889113 ↗MalfunctionJun 6, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE CHEST DRAIN VALVE FROM A WAYNE PNEUMOTHORAX SET LEAKED AND "SEPARATED AT THE PRESS FIT" DURING A THORACOSTOMY PROCEDURE. THE VALVE WAS REPLACED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22158213 ↗MalfunctionJun 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE COOK CHEST DRAIN VALVE (CDV) FROM A WAYNE PENUMOTHORAX SET LEAKED. THE DEVICE WAS REQUIRED FOR A THORACOSTOMY WITH CLOSED PLEURAL DRAINAGE PROCEDURE. AIR WAS DRAINED THROUGH THE LINE. AFTER THE DEVICE WAS PLACED, IT WAS DISCOVERED THAT THE CDV LEAKED. AS A RESULT, THE VALVE WAS REMOVED AND REPLACED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22145104 ↗MalfunctionApr 4, 2025Break; Break
IT WAS REPORTED THAT THE WIRE GUIDE INCLUDED IN THE WAYNE PNEUMOTHORAX SET SEPARATED DURING A THORACOSTOMY PROCEDURE ON A 63-YEAR-OLD MALE PATIENT. DURING PLACEMENT OF A LEFT WAYNE 14FR PIGTAIL CATHETER, THE WIRE GUIDE WAS FOUND TO BE BROKEN, WITH A PORTION RETAINED WITHIN THE CATHETER LUMEN. THE CATHETER AND WIRE WERE REMOVED TOGETHER IN ONE PIECE, WITH NO RETAINED MATERIAL, AS CONFIRMED BY A POST-REMOVAL CHEST X-RAY (CXR). AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21777737 ↗MalfunctionFeb 26, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE VALVE OF THE CHEST DRAIN INCLUDED IN WAYNE PNEUMOTHORAX SET LEAKED FOLLOWING ITS PLACEMENT IN A 40-YEAR-OLD FEMALE PATIENT TO MANAGE PNEUMOTHORAX. THE DEVICE WAS IN PLACE FOR ABOUT AN HOUR BEFORE THE LEAKAGE WAS OBSERVED. THE PATIENT WAS REPORTED TO BE BED BOUND. THE DOCTOR TOOK AVAILABLE MEASURES TO CONTROL THE PNEUMOTHORAX. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21469769 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE CHEST DRAIN VALVE OF A WAYNE PNEUMOTHORAX SET LEAKED. A LEAK IN THE CHEST DRAIN VALVE WAS DISCOVERED AFTER PLACING THE CHEST DRAINAGE CATHETER IN AN UNKNOWN PATIENT. THE CHEST DRAIN VALVE WAS CHANGED AND REPLACED BY A NEW ONE VIA "BICONICAL CONNECTION". AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20917687 ↗MalfunctionNov 5, 2024Unraveled Material; Unraveled Material
IT WAS REPORTED THAT THE WIRE GUIDE FROM A WAYNE PNEUMOTHORAX SET UNRAVELED. DURING DEVICE PLACEMENT, THE WIRE GUIDE KINKED AND WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A NEW DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A CUSTOMER PROVIDED PHOTO SHOWS THE WIRE GUIDE HAD UNRAVELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20609363 ↗MalfunctionOct 9, 2024Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component
THE COMPLAINT DEVICE WAS RETURNED TO COOK 26NOV2024 FOR EVALUATION. ONE USED WIRE GUIDE WAS RETURNED LODGED INSIDE THE CATHETER. THE WIRE GUIDE WAS UNRAVELED AS IT EXITED THE PROXIMAL END OF THE CATHETER HUB. BOTH WELD BALLS WERE INTACT. THE CATHETER AND ITS HUB APPEAR INTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20408665 ↗MalfunctionJun 17, 2024Unraveled Material; Deformation Due to Compressive Stress; Difficult to Advance; Unraveled Material; Deformation Due to Compressive Stress; Difficult to Advance
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 19552332 ↗MalfunctionMay 21, 2024Contamination; Contamination
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19359051 ↗MalfunctionMay 17, 2024Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19344566 ↗InjuryApr 12, 2024Break; Material Separation; Break; Material Separation
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 19101040 ↗InjuryFeb 16, 2024Use of Device Problem; Use of Device Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dyspnea; Increased Respiratory Rate; Swelling/ Edema
MAUDE report 18720096 ↗MalfunctionJan 4, 2024Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material
IT WAS REPORTED THAT THE WAYNE PNEUMOTHORAX SET WIRE GUIDE UNRAVELED. THE DRAINAGE CATHETER WAS PLACED IN THE CHEST. DURING REMOVAL OF THE WIRE GUIDE, IT WAS NOTED THE WIRE WAS STUCK IN THE CATHETER. THE ENTIRE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED. A PHOTO WAS PROVIDED WHICH SHOWS THE WIRE GUIDE UNRAVELED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18449575 ↗MalfunctionDec 19, 2023Unraveled Material; Unraveled Material
IT WAS REPORTED TO COOK THAT THE WIRE GUIDE OF A WAYNE PNEUMOTHORAX SET UNRAVELED. THE DEVICE WAS PLACED FOR MANAGEMENT OF A PNEUMOTHORAX. THE PATIENT DID NOT HAVE TORTUOUS ANATOMY. DURING THE PLACEMENT OF THE DRAIN THERE WAS NO DIFFICULTY WITH THE INSERTION OR ADVANCEMENT OF THE WIRE GUIDE. THE WIRE WAS NOT MANIPULATED OR WITHDRAWN THROUGH THE NEEDLE. THE WIRE GUIDE WAS WITHDRAWN FROM THE STRAIGHTENING OBTURATOR AND CATHETER. AFTER THE UNRAVELING OF THE WIRE GUIDE AND REMOVAL, A NEW DRAIN WAS PLACED. NO PART OF THE WIRE WAS RETAINED IN THE PATIENT. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION/MONITORING AND A BLOOD SAMPLE WAS TAKEN AFTER THE PLACEMENT OF THE SECOND DRAIN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18355356 ↗InjuryDec 14, 2023Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE STRAIGHTENING OBTURATOR WAS LEFT INSIDE THE CATHETER OF A WAYNE PNEUMOTHORAX SET FOLLOWING PLACEMENT INTO AN UNKNOWN PATIENT. THE PATIENT DEVELOPED A RIGHT PNEUMOTHORAX ON (B)(6) 2023. A WAYNE PIGTAIL CATHETER WAS INSERTED ON THE SAME DAY AT 1215 IN THE RIGHT ANTERIOR CHEST WITH BUBBLING NOTED IN THE CHEST DRAINAGE SYSTEM. HOWEVER, FROM TIME TO TIME, THE PATIENT'S SYSTOLIC BLOOD PRESSURE (SBP) DROPPED TO 70MMHG AND A LEVOPHED INFUSION WAS ADMINISTERED OFF AND ON. BUBBLING WAS STILL NOTED IN THE CHEST DRAINAGE SYSTEM ON 05NOV2023 AROUND 2300. THE PATIENT'S SBP THEN DROPPED TO 78MMHG AND LEVOPHED WAS RESTARTED AT 5MCG/MIN. THE INTENSIVE CARE UNIT (ICU) FELLOW WAS INFORMED, AND A REPEATED CHEST X-RAY SHOWED THAT THE RIGHT PNEUMOTHORAX HAD WORSENED CREATING A TENSION PNEUMOTHORAX AND HEMODYNAMIC INSTABILITY. THE PHYSICIAN CALLED THE TRAUMA SURGEON AND THE PATIENT'S PIGTAIL DRAIN WAS ASSESSED. THE SURGEON FOUND THAT THE OBTURATOR WAS STILL INSIDE OF THE PIGTAIL DRAIN. THE OBTURATOR WAS REMOVED AND CONNECTED TO A NEW CHEST DRAINAGE SYSTEM WITH A NEW CONNECTOR. BUBBLING WAS NOTED IN THE CHEST DRAINAGE SYSTEM AND THE PATIENT'S SBP WAS BACK TO 160-170MMHG FROM 120MM
Patient problems: Pneumothorax
MAUDE report 18327931 ↗MalfunctionNov 22, 2023Unraveled Material; Unraveled Material
AS REPORTED, THE WIRE GUIDE FROM A WAYNE PNEUMOTHORAX SET BROKE INSIDE A PATIENT DURING AN INTERVENTION. A PHOTO PROVIDED BY THE CUSTOMER SHOWS THE WIRE GUIDE UNRAVELED. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED TO CONFIRM NO PORTION OF THE DEVICE WAS RETAINED IN THE PATIENT; RESULTS ARE PENDING. THE PATIENT'S CONDITION WAS NOTED TO BE "GOOD". ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18193382 ↗MalfunctionOct 31, 2023Unraveled Material; Unraveled Material
PER ADDITIONAL INFORMATION PROVIDED ON 03NOV2023, THE PROCEDURE WAS COMPLETED WITH THE SELDINGER TECHNIQUE. THE WIRE GUIDE WAS NOT MANIPULATED NOR WITHDRAWN THROUGH THE NEEDLE. THE PHYSICIAN FELT A SNAP WHILE WITHDRAWING THE WIRE GUIDE THROUGH THE CATHETER AFTER THE NEEDLE HAD ALREADY BEEN WITHDRAWN. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS NOR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18043865 ↗MalfunctionOct 31, 2023Unraveled Material; Unraveled Material
IT WAS REPORTED THAT THE WIRE GUIDE FROM A WAYNE PNEUMOTHORAX SET UNRAVELED. AFTER PLACING THE CATHETER FOR CHEST DRAINAGE, THE WIRE EXPERIENCED RESISTANCE DURING ATTEMPTED REMOVAL. AS A RESULT, THE DEVICE WAS REMOVED IN ITS ENTIRETY TO ENSURE NO PORTION OF THE WIRE GUIDE REMAINED IN THE PATIENT. AFTER REMOVAL, IT WAS DISCOVERED THE WIRE GUIDE HAD UNRAVELED. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR'S DEVICE. THE CUSTOMER NOTED THERE WAS NO DIFFICULT ADVANCEMENT OF THE WIRE GUIDE. THE DIFFICULTY WAS ONLY EXPERIENCED DURING ATTEMPTED REMOVAL. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18039577 ↗MalfunctionAug 30, 2023Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak
THE INDICATION FOR PLACEMENT OF THE DEVICE WAS TO REMOVE AIR FROM THE PLEURAL SPACE. THE LEAKAGE WAS DISCOVERED WHEN THE PATIENT WENT BACK TO THE WARD. WHEN THE LEAKAGE IN THE CHEST DRAIN VALVE WAS DISCOVERED, THEY CHANGED TO USING DRAINAGE BOTTLES. THE PATIENT'S ACTIVITY LEVEL WAS DESCRIBED AS "NORMAL"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17650744 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.