Polysite 3017SPIRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03661234017584), received between May 10, 2019 and Jun 4, 2024 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Expulsion” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2024Migration or Expulsion of Device; Expulsion; Migration or Expulsion of Device; Expulsion

  PORT ERODING THROUGH THE SKIN. PORT WAS REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 19462175 ↗
• InjuryJun 4, 2024Migration or Expulsion of Device; Expulsion; Migration or Expulsion of Device; Expulsion

  PORT ERODING THROUGH THE SKIN. PORT WAS REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 19462174 ↗
• InjuryFeb 9, 2024Break; Material Separation; Expulsion; Break; Material Separation; Expulsion

  PORT SITE IS OPEN/INFECTED. PORT WAS REMOVED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 18677134 ↗
• MalfunctionFeb 6, 2024Expulsion; Separation Problem; Expulsion; Separation Problem

  PORT INSERTION SITE OPENED UP. REQUIRED PORT REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 18650587 ↗
• MalfunctionAug 11, 2023Disconnection; Disconnection

  PT ARRIVED FOR PORT STUDY POST-INFUSION ATTEMPT MALFUNCTION PORT NOTICED ON SCOUT IMAGE. PORT DISCONNECTED FROM CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 17508373 ↗
• InjuryOct 6, 2022Disconnection; Disconnection

  PORT 3017SPI PLACED ON (B)(6) 2022. ON (B)(6) 2022, FACILITY WAS UNABLE TO DO A BLOOD DRAW. UNDER SCAN, FACILITY NOTICED THAT THE CATHETER HAD "DETACHED" FROM THE PORT. DOCTOR USED A SNARE TO RETRIEVE THE CATHETER AND REMOVED THE PORT. UNDER EVALUATION, IT WAS STATED THE CATHETER DID NOT LOOK PUNCTURED, AND RATHER THAT IT JUST DETACHED. PATIENT IS GOING TO RECEIVE A PICC LINE INSTED OF A PORT GOING FORWARD.

  Patient problems: Insufficient Information

  MAUDE report 15548088 ↗
• InjuryNov 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE TELEFLEX NOTIFICATION SUMMARY REFERENCE (B)(4) RECEIVED ON OCTOBER 8TH 2019: "THE CATHETER DISLODGED FROM THE PORT INSIDE THE PATIENT. THEY HAD TO USE A SNARE TO REMOVE THE CATHETER ENDOVASCULARLY AND THEY REVISED THE PORT ANOTHER DAY ." THIS INCIDENT TOOK PLACE IN (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9282069 ↗
• InjuryMay 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE MEDWATCH (MW5081802): "UPON REMOVAL OF MEDIPORT IT WAS NOTED THAT THE CONNECTOR WAS NOT ATTACHED TO THE PORT ITSELF. FLUOROSCOPY WAS USED TO DETERMINE WHERE OR IF CONNECTOR WAS STILL IN THE PATIENT. BLUNT DISSECTION WAS UTILIZED TO RETRIEVE CONNECTOR WITH HEMOSTATS. NO DANGER TO PATIENT WAS NOTED AND NO POST PROCEDURE COMPLICATION WAS NOTED". THIS INFORMATION HAS BEEN RECEIVED FROM THE DISTRIBUTOR (B)(4) ON 02 JAN 2019 AT PEROUSE MEDICAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8600372 ↗