Dover P4P16TSDRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10884521066960), received between Jun 1, 2020 and Jul 13, 2021 — classified as 1 injury, 60 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (56 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY WAS INSERTED IN PROCEDURAL AREA AND DID NOT HAVE THE NEW SECUREMENT DEVICE. PATIENT WAS IN BED WITH STAFF BOOSTING THE PATIENT UP IN BED AND IT CAME APART. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163352 ↗
• MalfunctionJun 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE FOLEY SEPARATED FROM THE DRAINAGE BAG WHEN THE PATIENT WAS SITTING IN A CHAIR. THE PATIENT WAS A (B)(6) MALE CARDIAC SURGERY PATIENT. THE FOLEY WAS INSERTED IN THE OR AND CAME APART IN THE CSICU. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987041 ↗
• MalfunctionApr 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY SPONTANEOUSLY BROKE APART IN THE CSICU, THE CATHETER DETACHED FROM THE TUBING AT THE GREEN SEAL. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611273 ↗
• MalfunctionApr 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY SPONTANEOUSLY BROKE APART IN THE CSICU, THE CATHETER DETACHED FROM THE TUBING AT THE GREEN SEAL. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611261 ↗
• MalfunctionFeb 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE CATHETER IS COMING LOOSE AND DETACHING AT THE GREEN TAPE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307365 ↗
• MalfunctionJan 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT WHILE THE STUDENT NURSES WERE REPOSITIONING THE PATIENT, THE SILICONE FOLEY CATHETER DETACHED JUST ABOVE THE TAMPER EVIDENT SEAL. THE ISSUE WAS REPORTED TO THE ASSIGNED RN, WHO PASSED THE MESSAGE TO THE PROVIDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11233460 ↗
• MalfunctionJan 26, 2021Break; Break

  THE CUSTOMER REPORTED THAT IN (B)(6) 2020 THE PATIENT'S FOLEY CATHETER BROKE IN TWO AT THE SITE WHERE IT BRANCHES OFF FROM THE FOLEY PART TO THE HARD PLASTIC CONNECTION. PER THE PATIENT'S MOTHER SHE WAS PICKING THE PATIENT UP OUT OF THE CRIB AND BRINGING HER TO THE CHAIR TO HOLD HER. THE MOTHER CALLED OUT AND SAID THE FOLEY FELL OUT. WHEN THE RN EXAMINED THE PATIENT, THEY FOUND THE CATHETER ON THE FLOOR AND THE TIP STILL INSIDE THE PATIENT. THE REMAINING PORTION OF THE FOLEY WAS REMOVED BY THE RN/PROVIDERS ORDER. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11232681 ↗
• MalfunctionJan 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER CAME DISCONNECTED FROM GREEN SEAL ON CRITICALLY ILL PRONED/PARALYZED PATIENT. THE CATHETER WAS REMOVED TO BE REPLACED. THE PRONED PATIENT WAS TURNED ONTO SIDE TO RECATH, REQUIRING APPROXIMATE OF 15 MINUTES OF INTERVENTION CAUSING THE PATIENT TO DECOMPENSATE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE PATIENT'S POSITION WAS CHANGED TO SUPINE TO INSERT THE NEW FOLEY. NO TREATMENT WAS REQUIRED. THE PATIENT IS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11216641 ↗
• MalfunctionJan 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE FOLEY CATHETER BECAME DISCONNECTED FROM THE GRAVITY DRAINAGE BAG SPONTANEOUSLY. THE FOLEY CATHETER WAS LEFT OUT PER PROVIDER ORDER AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11208378 ↗
• MalfunctionJan 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE FOLEY CATHETER BECAME DISCONNECTED FROM THE DRAINAGE BAG. THE CATHETER WAS REPLACED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11208295 ↗
• MalfunctionJan 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE FOLEY CATHETER BECAME DISCONNECTED FROM THE BAG AT THE SEAL. THE CATHETER WAS REPLACED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11208204 ↗
• MalfunctionJan 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE FOLEY CATHETER BECAME DISCONNECTED AT THE CONNECTION POINT TO THE DRAINAGE BAG. THE CATHETER WAS FOUND ON THE FLOOR AND THE PATIENT WAS AGITATED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 11208090 ↗
• MalfunctionJan 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE FOLEY BECAME DETACHED AT THE PORT. THE CATHETER WAS REPLACED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11207950 ↗
• MalfunctionJan 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE COVIDIEN FOLEY CATHETER DISCONNECTED WHILE THE TAMPER EVIDENT SEAL REMAINED INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11204987 ↗
• MalfunctionJan 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTER AFTER AMBULATION, THE PATIENT'S FOLEY DRAINAGE BAG AND THE BLUE CATHETER HAD BECOME SEPARATED. THE TAMPER PROOF SEAL WAS STILL ON THE BLUE PART OF THE FOLEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11204908 ↗
• MalfunctionJan 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED 2 FOLEY CATHETERS FELL APART BACK-TO-BACK UPON BEING PLACED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11204817 ↗
• MalfunctionJan 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE GREEN SEAL MALFUNCTIONED ON THE CATHETER, RESULTING IN CATHETER DAMAGE AND DISCONNECTION. THE FOLEY CATHETER WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 11204054 ↗
• MalfunctionJan 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER TUBING BECAME DISLODGED FROM THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197936 ↗
• MalfunctionJan 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER TUBING BECAME DISCONNECTED REQUIRING PLACEMENT OF NEW FOLEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197927 ↗
• MalfunctionJan 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER DISCONNECTED FROM TAMPER RESISTANT SEAL, WHILE PATIENT WAS SLEEPING IN BED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197909 ↗
• MalfunctionJan 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER DISCONNECTED, WHILE TAMPER SEAL REMAINED INTACT. THE FOLEY WAS PLACED ON (B)(6) 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197894 ↗
• MalfunctionJan 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER SPONTANEOUSLY BECAME DISCONNECTED FROM THE GRAVITY DRAINAGE BAG. THE GREEN PLASTIC AT THE END OF THE CATHETER WAS STILL INTACT. THE FOLEY CATHETER WAS REMOVED AND REPLACED WITH A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197891 ↗
• MalfunctionJan 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER CAME UNATTACHED AT THE GREEN PIECE (FOLEY TO BAG PART). THE FOLEY WAS REMOVED AND NEW ONE WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197814 ↗
• MalfunctionJan 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER CAME APART AT THE CONNECTION TO DRAINAGE BACK WITH THE GREEN SECURE WRAPPING INTACT. THIS IS THE SECOND TIME TODAY FOR THIS PATIENT. AFTER THE FIRST DISCONNECTION, THE CATHETER WAS REPLACED AND THE GREEN SECURE WRAPPING WAS ALSO SECURED WITH TAPE BUT, IT DID NOT HOLD AND REQUIRED THE CATHETER TO BE REPLACED ON THIS PATIENT FOR THE SECOND TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197783 ↗
• MalfunctionJan 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER CAME APART AT GREEN SEAL, WHERE CATHETER CONNECTS TO DRAINAGE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197757 ↗