Wayne G56537Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00827002565371), received between Jun 14, 2018 and Mar 20, 2026 — classified as 11 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (12 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Mar 5, 2026Open, Classified

   Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

   Z-1792-2026 · Root cause: Incorrect or no expiration date · FDA record ↗

2. Mar 5, 2026Open, Classified

   Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

   Z-1791-2026 · Root cause: Incorrect or no expiration date · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Unraveled Material

  IT WAS REPORTED THAT THE WIRE GUIDE INCLUDED IN A WAYNE PNEUMOTHORAX TRAY WAS DIFFICULT TO REMOVE AND UNRAVELED. THE WAYNE CHEST TUBE WAS THREADED OVER THE WIRE AS PER THE USUAL. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE WIRE AND OBTURATOR WITH A NORMAL AMOUNT OF FORCE, THE WIRE "STRETCHED". MANY ATTEMPTS WERE MADE TO RELEASE THE WIRE WITH NO SUCCESS. THEY ULTIMATELY REMOVED ALL DEVICE COMPONENTS TOGETHER. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. NO UNINTENDED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT. A CUSTOMER PROVIDED PHOTO REVEALS AN UNRAVELED WIRE GUIDE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649996 ↗
• MalfunctionFeb 9, 2026Unraveled Material

  IT WAS REPORTED THAT THE WIRE GUIDE FROM A WAYNE PNEUMOTHORAX TRAY WAS "FRAYED". AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299949 ↗
• InjuryJan 21, 2026Use of Device Problem

  IT WAS REPORTED THAT IN (B)(6) 2025, THE OBTURATOR OF A WAYNE PNEUMOTHORAX TRAY WAS NOT REMOVED FROM THE CATHETER. A 17-YEAR-OLD MALE PATIENT UNDERWENT PLACEMENT OF A WAYNE CHEST TUBE FOR TREATMENT OF A LARGE LEFT-SIDED PNEUMOTHORAX. ULTRASOUND WAS USED PRIOR TO INITIATING THE PROCEDURE TO EVALUATE APPROPRIATE ANATOMY, AND THE SKIN SITE WAS MARKED AT THE 3RD-4TH INTERCOSTAL SPACE ABOVE THE RIB. A NEEDLE WAS INSERTED IN THE MID AXILLARY LINE AT THE 3RD AND 4TH INTERCOSTAL SPACE OF THE FOURTH RIB, AND THIS WAS ADVANCED UNTIL AIR WAS ASPIRATED TO THE SYRINGE. SELDINGER TECHNIQUE WAS USED TO ADVANCE THE WIRE, FOLLOWED BY A SMALL 0.5 CM INCISION WITH A SCALPEL AND THEN DILATION WITH THE DILATING CATHETER. THE NEEDLE AND DILATOR WERE REMOVED, AND THE 12 FRENCH PIGTAIL CATHETER WAS INSERTED OVER THE WIRE. THE CATHETER WAS ADVANCED SUPERIORLY WITHOUT COMPLICATION AND SECURED WITH A 5-0 NON-ABSORBABLE, SYNTHETIC SUTURE. THE CHEST TUBE INSERTED EASILY WITHOUT COMPLICATION. THERE WAS MINIMAL BLEEDING DURING THE PROCEDURE. THE CHEST TUBE WAS SECURED, CONNECTED TO A COMPETITOR'S DRAINAGE SYSTEM, AND SET TO -20 CM WATER SUCTION. PATIENT BECAME MILDLY HYPOXIC TO THE UPPER 80% AND WAS PLACED ON 2

  Patient problems: Pneumothorax

  MAUDE report 24131622 ↗
• InjuryDec 30, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE OBTURATOR OF A WAYNE PNEUMOTHORAX TRAY WAS LEFT IN THE LUMEN OF THE CATHETER FOLLOWING INSERTION INTO AN UNKNOWN PATIENT. THE NURSE NOTED THAT, WHILE ASSISTING THE PATIENT TO THE RESTROOM, THE CHEST TUBE BECAME DISCONNECTED. UPON FURTHER INSPECTION AND A DISCUSSION WITH THE PEDIATRIC INTENSIVE CARE UNIT (PICU) INTENSIVIST AND SURGICAL TEAM, IT WAS DETERMINED THAT THE CHEST TUBE HAD BEEN CONNECTED INCORRECTLY AT THE TIME OF INSERTION. SPECIFICALLY, THE OBTURATOR HAD BEEN INADVERTENTLY LEFT IN THE CHEST TUBE LUMEN AND THEN CONNECTED TO THE VACUUM SEAL. THIS RESULTED IN SIGNIFICANT OBSTRUCTION, LIMITING THE CHEST TUBE'S ABILITY TO RESOLVE THE PNEUMOTHORAX. THE PATIENT WAS THEN SCHEDULED FOR OPERATING ROOM (OR) REPLACEMENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAVE BEEN REQUESTED BUT ARE CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information; Pneumothorax

  MAUDE report 23928347 ↗
• InjuryNov 3, 2025Use 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: Dyspnea; Hypoventilation; Mediastinal Shift; Swelling/ Edema

  MAUDE report 23456445 ↗
• MalfunctionOct 22, 2025Entrapment of Device; Device Markings/Labelling Problem

  INTRODUCER WAS LEFT IN THE CHEST TUBE AFTER THE COMPLETION OF THE PROCEDURE. WOULD RECOMMEND COOK TO CONSIDER MODIFICATION OF THE INTRODUCER WITH A LABEL OR FITTING TO MAKE ITS PRESENCE MORE NOTABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23356236 ↗
• MalfunctionOct 10, 2025Break; Break

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23271062 ↗
• InjurySep 12, 2025Break; Break

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23039829 ↗
• InjuryJun 24, 2025Break; Break

  IT WAS REPORTED THAT THE WIRE GUIDE FROM A WAYNE PNEUMOTHORAX TRAY BROKE DURING A PROCEDURE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 22321898 ↗
• MalfunctionFeb 24, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT A WIRE GUIDE FROM A WAYNE PNEUMOTHORAX TRAY FRAYED DURING AN UNKNOWN PROCEDURE. IT IS UNKNOWN IF THE WIRE GUIDE WAS MANIPULATED OR REMOVED THROUGH THE ENTRY NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. 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 21452815 ↗
• MalfunctionDec 13, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE WIRE GUIDE INCLUDED IN THE WAYNE PNEUMOTHORAX TRAY UNRAVELED DURING A CATHETER PLACEMENT PROCEDURE FOR A PATIENT OF UNKNOWN AGE AND GENDER. DURING PLACEMENT OF THE 14FR CATHETER, THE CUSTOMER NOTED THAT THE WIRE GUIDE "COMPLETELY CAME APART." THE PROCEDURE WAS DISCONTINUED AND RESTARTED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926488 ↗
• MalfunctionNov 15, 2024Break; Unraveled Material; Break; Unraveled Material

  ADDITIONAL INFORMATION WAS PROVIDED 12DEC2024. THE DEVICE WAS REQUIRED FOR A LATERAL THORACOSTOMY TO TREAT A PNEUMOTHORAX. DURING PLACEMENT, THE WIRE WAS ADVANCED THROUGH THE NEEDLE, THEN THE NEEDLE WAS REMOVED OVER THE WIRE WITH NORMAL SELINGER TECHNIQUE. AS REPORTED, "ALL OF THE PIECES OF THE WIRE WERE STILL CONNECTED, HOWEVER THE WIRE WAS FRAYED [AND] NEAR SPLITTING INTO TWO PIECES". THE WIRE WAS REMOVED FROM THE PATIENT IN ITS ENTIRETY. THE PROCEDURE WAS ABORTED, AND SHORTLY AFTER, AN ADDITIONAL WAYNE DEVICE WAS OBTAINED TO COMPLETE THE THORACOSTOMY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695614 ↗
• MalfunctionJul 24, 2024Unraveled Material; Unraveled Material

  THE WIRE GUIDE WAS NOT MANIPULATED OR REMOVED THROUGH THE ACCESS NEEDLE. IT WAS MANIPULATED OR REMOVED THROUGH THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819596 ↗
• InjuryJun 3, 2024Break; Break

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19453825 ↗
• InjuryApr 5, 2024Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  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 19050075 ↗
• InjurySep 15, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE OBTURATOR WAS INADVERTENTLY LEFT INSIDE OF THE CATHETER INCLUDED IN THE WAYNE PNEUMOTHORAX TRAY FOLLOWING CHEST TUBE PLACEMENT IN A 22-YEAR-OLD MALE TRAUMA PATIENT. THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY (IR) FOR A CHEST TUBE PLACEMENT PROCEDURE; HOWEVER, IT WAS REPORTED THAT THE PNEUMOTHORAX PERSISTED DESPITE TREATMENT. DURING A REPLACEMENT PROCEDURE ON (B)(6) 2023, IT WAS DISCOVERED THAT THE OBTURATOR HAD BEEN RETAINED IN THE ORIGINAL CHEST TUBE. THE IR NURSE NOTED THAT PRIOR TO THE START OF THE INITIAL PLACEMENT PROCEDURE, THE OBTURATOR WAS ALREADY IN PLACE AND LIKELY NEVER REMOVED. IT WAS LATER REPORTED THAT THE CHEST TUBE COULD BE LUER LOCKED ONTO SUCTION WITH THE OBTURATOR IN PLACE, MOST LIKELY LEADING TO THE TECHNICAL ERROR BY THE TRAUMA SURGEON.

  Patient problems: Pneumothorax

  MAUDE report 17760010 ↗
• MalfunctionJul 26, 2022Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE WIRE INCLUDED IN A WAYNE PNEUMOTHORAX TRAY BECAME FRAYED DURING USE WITH A CHEST TUBE. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15106118 ↗
• InjuryJun 10, 2022Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REQUIRED A WAYNE PNEUMOTHORAX TRAY FOR A CHEST TUBE PLACEMENT. AFTER PLACEMENT, IT WAS DISCOVERED THE USER HAD INSERTED THE CHEST DRAIN VALVE BACKWARDS, NOT ALLOWING AIR TO EXIT THE CHEST/PLEURAL SPACE. THIS RESULTED IN WORSENING OF THE PATIENT'S PNEUMOTHORAX. IT IS NOT KNOWN AT THIS TIME HOW MUCH TIME ELAPSED FROM PLACEMENT UNTIL DISCOVERY AND WHAT SPECIFIC INTERVENTIONS WERE PERFORMED. THE DEVICE WAS EXPLANTED ON (B)(6) 2022. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Pneumothorax

  MAUDE report 14658820 ↗
• InjuryApr 22, 2022Device Markings/Labelling Problem; Misassembly by Users

  COOK MEDICALS "WAYNE PNEUMOTHORAX TRAY" C-UTPTY-1400-WAYNE-112497-IMH, G56637, LOT # 14121501. THE TRAY HAS A HEIMLICH VALVE IN IT THAT WAS INCORRECTLY INSERTED BACKWARDS BY PROVIDER AND DID NOT ALLOW AIR TO EXIT CHEST/PLEURAL SPACE AND RESULTED IN WORSENING OF PATIENT'S PNEUMOTHORAX. THE HEIMLICH VALVE DOES NOT HAVE MARKINGS ON IT THAT ARE EASY TO READ AND ARE OF THE SAME COLOR (CLEAR PLASTIC). THERE IS A DISPOSABLE PAPER DIAGRAM THAT WAS NOT CLEAR TO PROVIDER DURING URGENT IMPLANTATION OF HOW TO ATTACH TO CATHETER/TUBING. NO OTHER INSTRUCTIONS FOR USE WERE PRESENT IN THE KIT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14195101 ↗
• InjuryApr 18, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CONNECTION BETWEEN AN UNKNOWN COOK CATHETER AND PLEUREVAC KINKED. A PATIENT DEVELOPED SIGNIFICANT SUBCUTANEOUS EMPHYSEMA INVOLVING THE CHEST, ARMS, AND FACE. THE PATIENT'S EYES WERE ALSO SWOLLEN SHUT. THE CARE TEAM CONSIDERED PLACING A LARGE BORE CHEST TUBE TO TREAT. HOWEVER, IT WAS IDENTIFIED THAT THERE WAS A KINK IN THE CONNECTING TUBE. IT WAS REPORTED THAT THE PHYSICIANS HAD TO FIND "A CREATIVE WAY" TO STRAIGHTEN THE CONNECTING TUBE AND TAPE IT TO THE BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED AT THE TIME OF THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pneumothorax; Swelling/ Edema

  MAUDE report 14136610 ↗
• MalfunctionDec 28, 2021Output Problem

  PLACEMENT OF PIGTAIL AT BEDSIDE, OBTURATOR STOPCOCK ALLOWS FOR CONNECTION TO SUCTION, NO EQUIPMENT "HARD STOP" THAT STYLET/OBTURATOR ATTACHED TO SUCTION AND NOT REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 13093104 ↗
• MalfunctionApr 27, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  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 11731005 ↗
• MalfunctionApr 26, 2021Unraveled 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 11726705 ↗
• MalfunctionMar 19, 2021Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IN ADDITIONAL INFORMATION RECEIVED ON 28APR2021, IT WAS REPORTED THAT THE WIRE GUIDE SEPARATED DURING ADVANCEMENT OF THE CATHETER. THE WIRE GUIDE "SNAPPED AND UNRAVELED" AND WAS UNABLE TO BE REMOVED WHEN THE TUBE WAS PULLED OUT. SUTURES WERE NOT APPLIED. A SECOND TUBE WAS SUCCESSFULLY INSERTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11527322 ↗
• MalfunctionNov 5, 2020Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING IMPLANTATION, WHILE PLACING THE CHEST TUBE, THE GUIDEWIRE OF A WAYNE PNEUMOTHORAX TRAY UNRAVELED. THE GUIDEWIRE WAS ABLE TO BE RETRIEVED ENTIRELY. THE CHEST TUBE WAS REINSERTED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10794440 ↗