WayneRecalls & reported problems across all models
Cook Incorporated · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Wayne model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 138
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls
- 2
We found 7 models of Wayne by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 138 adverse event reports in the FDA's MAUDE database, received between Nov 10, 2016 and Sep 29, 2026 — classified as 27 injuries, 111 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (34 reports).
2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Wayne recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
Most reported Wayne problems
Device problems
- Unraveled Material34
- Material Separation20
- Device Contaminated During Manufacture or Shipping17
- Leak/Splash16
- Break14
- Use of Device Problem8
- Difficult to Remove7
- Device Contamination with Chemical or Other Material5
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- No Patient Involvement25
- No Known Impact Or Consequence To Patient17
- Insufficient Information14
- No Consequences Or Impact To Patient12
- Pneumothorax12
- Foreign Body In Patient6
- No Code Available6
Wayne models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Wayne G56537CATHETER AND TIP, SUCTION2 recalls33 reports
- Wayne G56535CATHETER AND TIP, SUCTION50 reports
- Wayne G56533CATHETER AND TIP, SUCTION27 reports
- Wayne G11182CATHETER AND TIP, SUCTION23 reports
- Wayne G09922CATHETER AND TIP, SUCTION2 reports
- Wayne G56532CATHETER AND TIP, SUCTION2 reports
- Wayne G07910CATHETER AND TIP, SUCTION1 report
Recent Wayne adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934312 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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