PowerPICC® Catheter 3275108Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741000423), received between Mar 24, 2022 and Nov 17, 2022 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (17 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "WE NEEDED TO REPLACE LINE ON PATIENT. THE "HUB" WAS LEAKING ONLY WHEN A CONNECTOR WAS APPLIED, THE SYRINGE ATTACHED DIRECTLY TO THE HUB DID NOT PRODUCE ANY KIND OF LEAKING WITH FLUSHING. HOWEVER, WHEN THE CONNECTOR WAS APPLIED, IT WAS NOTED TO LEAK AROUND THAT CONNECTION WITH ANY KIND OF FLUSHING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814639 ↗
• MalfunctionNov 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "WE NEEDED TO REPLACE LINE. THE "HUB" WAS LEAKING ONLY WHEN A CONNECTOR WAS APPLIED, THE SYRINGE ATTACHED DIRECTLY TO THE HUB DID NOT PRODUCE ANY KIND OF LEAKING WITH FLUSHING. HOWEVER, WHEN THE CONNECTOR WAS APPLIED, IT WAS NOTED TO LEAK AROUND THAT CONNECTION WITH ANY KIND OF FLUSHING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15809855 ↗
• MalfunctionNov 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "WE NEEDED TO REPLACE LINE, THE "HUB" WAS LEAKING ONLY WHEN A CONNECTOR WAS APPLIED, THE SYRINGE ATTACHED DIRECTLY TO THE HUB DID NOT PRODUCE ANY KIND OF LEAKING WITH FLUSHING. HOWEVER, WHEN THE CONNECTOR WAS APPLIED, IT WAS NOTED TO LEAK AROUND THAT CONNECTION WITH ANY KIND OF FLUSHING.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15781308 ↗
• MalfunctionNov 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "WE NEEDED TO REPLACE LINE, THE "HUB" WAS LEAKING ONLY WHEN A CONNECTOR WAS APPLIED, THE SYRINGE ATTACHED DIRECTLY TO THE HUB DID NOT PRODUCE ANY KIND OF LEAKING WITH FLUSHING. HOWEVER, WHEN THE CONNECTOR WAS APPLIED, IT WAS NOTED TO LEAK AROUND THAT CONNECTION WITH ANY KIND OF FLUSHING.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15780684 ↗
• MalfunctionJul 7, 2022Defective Component; Defective Component

  IT WAS REPORTED VIA MS&S " CALLER STATES SHE HAS A PATIENT WITH THE 5 FR DL POWER PICC. CALLER STATES THE CLAMP IS BROKEN OFF AND IS A SAFETY ISSUE. THE FACILITY THAT PLACED THE PICC LINE BROKE THE CLAMP AND SENT THE PATIENT HOME WITH IT. CALLER IS ASKING FOR OUR RECOMMENDATIONS REGARDING USING THE LINE. IS THE CLAMP REPLACEABLE OR SHOULD THE LINE BE REMOVED? CALLER STATES SHE HAS NOT INFORMED HER PROVIDER BUT WILL HAVE THE PROVIDER ASSESS THE LINE." MS&S INFORMED CALLER WE DO NOT OFFER CLAMPS SEPARATELY TO REPLACE THE BROKEN CLAMPS. INFORMED CALLER THE CLAMP IS A SAFETY FEATURE FOR THE OPEN ENDED PICCS. WITHOUT THE PICC CLAMP, AIR CAN ENTER THE LINE OR THE PATIENT CAN BLEED OUT IF THE CONNECTOR BECOMES DISCONNECTED. AN IV EXTENSION WITH A CLAMP COULD BE ADDED TO THE LUMEN TO ALLOW FOR CLAMPING, HOWEVER THE PATIENT AND ANYONE CARING FOR THE LINE WOULD NEED TO BE AWARE OF THE BROKEN CLAMP. SUGGESTED CALLER CONSULT THE PROVIDER TO ASSESS THE LINE AND DETERMINE IF IT SHOULD BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14952052 ↗
• MalfunctionJul 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN OVER-WIRE EXCHANGE WAS PERFORMED, THE RN REPORTS IT WAS LEAKING WITH EVEN WITH SYRINGE FLUSHING. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14918724 ↗
• MalfunctionJul 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT NOTED A LEAK AROUND THE CONNECTION WITH ANY KIND OF FLUSHING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14918680 ↗
• MalfunctionJul 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE "HUB" WAS LEAKING ONLY WHEN A CONNECTOR WAS APPLIED, THE SYRINGE ATTACHED DIRECTLY TO THE HUB DID NOT PRODUCE ANY KIND OF LEAKING WHEN FLUSHING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14918675 ↗
• MalfunctionJul 1, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT AN OVER-WIRE EXCHANGE WAS PERFORMED, THE RN REPORTS IT WAS LEAKING WITH EVEN WITH SYRINGE FLUSHING. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14896778 ↗
• InjuryJun 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC THAT WAS FOUND TO BE LEAKING AT THE PURPLE HUB." ADD INFO RCVD 06/06/2022: VAST CALLED TO DISCONTINUE PATIENT'S PICC DUE TO LINE INFECTION. PATIENT STATES THAT IT HAS BEEN LEAKING FROM THE PURPLE LUMEN AT THE HUB FOR A FEW DAYS. PATIENT STATES THAT SHE DID VERBALIZE THIS TO NURSING STAFF. I DID SEE THAT IT WAS LEAKING BETWEEN THE PURPLE LUMEN AND THE CAP AT THE TIME OF REMOVAL. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? UNKNOWN. WAS THE PRODUCT USED ON A PATIENT? YES. WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME: THERE WAS NO HARM DOCUMENTED, BUT THEY DID LIST THE FAILURE AS ¿TEMP HARM, REQUIRING INITIAL OR PROLONGED HOSPITALIZATION¿. REPORT ALSO STATES: IF A PATIENT OR STAFF REPORTS/SUSPECTS A LINE IS LEAKING THEN VAST SHOULD BE NOTIFIED FOR FURTHER ASSESSMENT. THE LINE COULD BE DEFECTIVE AND/OR SOURCE OF INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 14735183 ↗
• MalfunctionJun 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC LEAKING AT HUB." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599217 ↗
• MalfunctionMay 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC LINE REPORTEDLY LEAKING FROM NEAR END CAP ON PURPLE PORT AND CAP, CHANGED CAP AND MADE SURE ON TIGHTLY, BUT STILL NOTED LEAKING NEAR PORT. NO LEAKING WAS NOTED WHEN PORT FLUSHED DIRECTLY WITH NO CAP. NO OTHER ISSUE NOTED WITH PICC. PICC NURSE NOTIFIED AND STATED SHE WOULD COME ASSESS THURSDAY (B)(6) 2022 AND BRING A DIFFERENT TYPE OF CAP. ADVISED TO CLAMP PORT AND NOT USE PURPLE PORT UNTIL FURTHER ASSESSED ON THURSDAY. NURSE AWARE AND PORT IS CAPPED/CLAMPED AND COVERED TO INDICATE NOT TO BE USED AT THIS TIME." ADDITIONAL INFORMATION RECEIVED 04/26/2022 ANY PATIENT SYMPTOMS RELATED TO FLUID LEAK? NO. WAS THE CATHETER REMOVED? WAS A NEW CATHETER PLACED? NO, THE PURPLE PORT WAS CLAMPED AND NOT USED. NURSING CONSULTED PICC NURSE AND WAS ADVISED TO CLAMP AND NOT USE PORT UNTIL SHE COULD BRING AN ALTERNATE CAP; PICC NURSE STATED THAT THIS HAS HAPPENED BEFORE AND SHE TRIED A DIFFERENT CAP AND IT RESOLVED THE ISSUE. WE WERE NOT AWARE OF ANY PRIOR ISSUES WITH THE PORTS. PICC NURSE PLACED A DIFFERENT CAP ON (B)(6) 2022 AND THE ISSUE WAS RESOLVED. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STATLOCK DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14383820 ↗
• MalfunctionMay 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC LINE PLACED BY PICC NURSE AS ORDERED AND NOTED THAT IT WAS LEAKING AROUND CAP ON THE PURPLE PORT. PICC NURSE DID NOT HAVE THE DIFFERENT TYPE OF CAPS WITH HER THAT WERE EFFECTIVE IN CORRECTING THE ISSUE IN THE PAST, SO A PIGTAIL EXTENSION WAS PLACED WHICH CORRECTED THE ISSUE." ADDITIONAL INFORMATION RECEIVED 04/26/2022: "I HAVE NO OTHER INFORMATION ON THIS OCCURRENCE. PICC NURSE JUST STATED THAT SHE HAS SEEN THIS HERE BEFORE. UNSURE OF TIMEFRAME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14382884 ↗
• MalfunctionMay 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC LINE REPORTEDLY LEAKING FROM NEAR END CAP ON PURPLE PORT AND CAP, CHANGED CAP AND MADE SURE ON TIGHTLY, BUT STILL NOTED LEAKING NEAR PORT. NO LEAKING WAS NOTED WHEN PORT FLUSHED DIRECTLY WITH NO CAP. NO OTHER ISSUE NOTED WITH PICC." ADDITIONAL INFORMATION RECEIVED 04/26/2022: PICC LINE PLACED BY PICC NURSE AS ORDERED AND NOTED THAT IT WAS LEAKING AROUND CAP ON THE PURPLE PORT. PICC NURSE DID NOT HAVE THE DIFFERENT TYPE OF CAPS WITH HER THAT WERE EFFECTIVE IN CORRECTING THIS ISSUE, SO A PIGTAIL EXTENSION WAS PLACED WHICH CORRECTED THE ISSUE. DOUBLE LUMEN PICC - BARD". AFTER INSERTION WHEN FLUSHING: WAS THE CATHETER FRACTURE INTERNAL TO THE PATIENT OR EXTERNAL? EXTERNAL. WHAT WAS INFUSION WHEN THE LEAK WAS DISCOVERED? NORMAL SALINE FLUSH. ANY PATIENT SYMPTOMS RELATED TO FLUID LEAK? NO. WAS THE CATHETER REMOVED? WAS A NEW CATHETER PLACED? NO. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STATLOCK DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14382688 ↗
• MalfunctionApr 7, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED VIA PHONE CALL "PICC IS LEAKING AT THE PURPLE HUB." ADDITIONAL INFORMATION RECEIVED 03/17/2022 IT WAS REPORTED "PLACE A DOUBLE LUMEN PICC LINE IN PATIENT. ATTACHED MICROCLAVE (END CAP) TO BOTH LUMENS OF THE PICC. FLUSHED BOTH LUMENS WITH 10 ML OF NORMAL SALINE. NOTED LEAKING BETWEEN MICROCLAVE AND HUB OF PICC LINE. REMOVED AND REPLACED A DIFFERENT MICROCLAVE WITH THE SAME RESULTS. PICC LINE WAS EXCHANGED. NO LEAKING NOTED. AT WHAT POINT DURING DEVICE USE WAS THE LEAK DISCOVERED: INFUSION, EXTERNAL WHAT WAS INFUSION WHEN THE LEAK WAS DISCOVERED? UNKNOWN ANY PATIENT SYMPTOMS RELATED TO FLUID LEAK? NO WAS THE CATHETER REMOVED? WAS A NEW CATHETER PLACED? YES, YES WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? UNKNOWN PLACEMENT DATE: UNKNOWN EXPLANT DATE: (B)(6) 2022. WAS THERE ANY PATIENT HARM REPORTED? NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14044991 ↗
• MalfunctionApr 7, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED VIA PHONE CALL "PRODUCT IS LEAKING AT THE PURPLE HUB." ADDITIONAL INFO. RECEIVED 03/17/2022 DOUBLE LUMEN PICC PLACED WITH DATE REC'D BY MFR (UNIT #10). PRIOR TO PLACEMENT IN PATIENT WHILE STERILE, BOTH LUMENS WERE FLUSHED WITH STERILE SALINE AND NO ABNORMAL LEAKING NOTED. LINE WAS PLACED IN PATIENT WITHOUT INCIDENT. NEEDLELESS CONNECTOR CAPS WERE APPLIED AND PURPLE LUMEN WAS NOTED TO LEAK WHEN FLUSHED WITH SALINE; LEAK NOTED UNDER CAP AT PURPLE LUMEN JOINING. RN ASSISTED IN PROVIDING MULTIPLE REPLACEMENT CAPS WHICH ALL DEMONSTRATED LEAKING. WHEN SALINE HOOKED DIRECTLY TO HUB, NO LEAK NOTED. UNABLE TO SAFELY LEAVE LINE IN PLACE AND REQUIRED ADDITIONAL PROCEDURE TO EXCHANGE PICC LINE. AT WHAT POINT DURING DEVICE USE WAS THE LEAK DISCOVERED (I.E. INSERTION, INFUSION, REMOVAL) WAS THE CATHETER FRACTURE INTERNAL TO THE PATIENT OR EXTERNAL? INFUSION, EXTERNAL ANY PATIENT SYMPTOMS RELATED TO FLUID LEAK? NO WAS THE CATHETER REMOVED? WAS A NEW CATHETER PLACED? YES, YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14044644 ↗
• MalfunctionMar 25, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED VIA PHONE CALL "PRODUCT THAT IS LEAKING AT THE PURPLE HUB." ADDITIONAL INFO. RECEIVED 03/17/2022: A DETAILED DESCRIPTION OF THE EVENT: PICC PLACED FOR TPN, WHEN FLUSHING PURPLE LUMEN, FLUID WOULD LEAK FROM THE HUB, TIGHTENED SEVERAL TIMES, CAP ADDED AND CHANGED SEVERAL TIMES, CONTINUE TO LEAK. SECOND VAST NURSE AT BEDSIDE COLLABORATED ISSUE. PICC EXCHANGED AND PROBLEM RESOLVED. AT WHAT POINT DURING DEVICE USE WAS THE LEAK DISCOVERED (I.E. INSERTION, INFUSION, REMOVAL) WAS THE CATHETER FRACTURE INTERNAL TO THE PATIENT OR EXTERNAL? INFUSION, EXTERNAL. WHAT WAS INFUSION WHEN THE LEAK WAS DISCOVERED? UNKNOWN. ANY PATIENT SYMPTOMS RELATED TO FLUID LEAK? NO. WAS THE CATHETER REMOVED? WAS A NEW CATHETER PLACED? YES AND YES. WAS THE PRODUCT USED ON A PATIENT? YES. WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME. NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13908578 ↗
• MalfunctionMar 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "CUSTOMER REPORTED THE PURPLE POWER LUMEN WAS LEAKING AFTER CONNECTOR WAS PLACED AND LUMEN WAS FLUSHED. CONNECTOR WAS TRIED ON NON POWER LUMEN AND IT DID NOT LEAK. CUSTOMER TRIED MULTIPLE CONNECTORS AND IT ONLY LEAKED AT THE PURPLE LUMEN WHEN CUSTOMER FLUSHED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13895183 ↗