PowerPICC Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet 1275118Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00801741034589), received between Oct 27, 2017 and Sep 14, 2026 — classified as 2 deaths, 4 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Defective Component” (27 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 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765659 ↗
• MalfunctionFeb 18, 2026Material Deformation

  IT WAS REPORTED THE NEEDLELESS CONNECTOR OF THE PURPLE LUMEN OF A DL PICC WAS NOT BEING ABLE TO BE REMOVED. THE PATIENT REPORTED ONGOING ISSUES WITH THE PURPLE LUMEN CAP GETTING "STUCK" ON IT. WHEN I ASSESSED, THERE WAS CLEAR INDICATION THAT SOMEONE HAD APPLIED A CLAMP TO TRY TO REMOVE THE NEEDLELESS CONNECTOR AS THERE WERE SCORE MARKS ON THE HUB. ULTIMATELY, THE TEAM OPTED TO REMOVE THIS PICC FROM THE PATIENT, BOTH DUE TO THE DAMAGE ON THE HUB AND THE FACT THAT THE NEEDLELESS CONNECTOR WOULD NOT COME LOOSE. THE PICC WAS REPLACED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378812 ↗
• MalfunctionAug 15, 2025Dull, Blunt; Failure to Cut

  WHEN RN WENT TO TRIM THE PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] LINE WITH THE STANDARD GREEN BARD RAZOR THAT COMES IN THE KIT USED TO TRIM THE CATHETER, THE RAZOR DID NOT TRIM THE CATHETER AFTER MULTIPLE ATTEMPTS. THE RAZOR WAS BLUNTED AND A SUTURE REMOVAL KIT AND STERILE SCISSORS WAS USED TO TRIM THE CATHETER TO THE LENGTH NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814237 ↗
• MalfunctionAug 1, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE "BUCKLING" WAS OCCURRING QUITE FREQUENTLY, AND THEY HAD TO ADAPT THEIR DILATION TECHNIQUE TO ACCOMMODATE FOR IT (LARGER NICK IN THE SKIN, STRETCH AND PAUSE BEFORE CONTINUING, AND HOLDING MUCH CLOSER TO HUB OF DILATOR).  MOST OFTEN, THE DILATOR WOULD JUST BUCKLE AND NOT CREATE THE ROUGH EDGE, BUT SOMETIMES IT CREATED THE ROUGH EDGE MAKING IT UNUSABLE. THE DILATORS ARE UNUSABLE AND HAD TO BE REPLACED MID-PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22688244 ↗
• MalfunctionAug 1, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE "BUCKLING" WAS OCCURRING QUITE FREQUENTLY, AND THEY HAD TO ADAPT THEIR DILATION TECHNIQUE TO ACCOMMODATE FOR IT (LARGER NICK IN THE SKIN, STRETCH AND PAUSE BEFORE CONTINUING, AND HOLDING MUCH CLOSER TO HUB OF DILATOR). MOST OFTEN, THE DILATOR WOULD JUST BUCKLE AND NOT CREATE THE ROUGH EDGE, BUT SOMETIMES IT CREATED THE ROUGH EDGE MAKING IT UNUSABLE. THE DILATORS ARE UNUSABLE AND HAD TO BE REPLACED MID-PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22688227 ↗
• MalfunctionJul 10, 2025Material Deformation; Material Deformation

  IT WAS REPORTED "I WAS INSERTING A DUAL LUMEN BARD POWER PICC. WHEN I USED THE DILATOR INCLUDED IN THE PICC KIT, THE EDGE OF THE EXTERNAL SHEATH "BUCKLED" AT THE TIP CREATING A ROUGH EDGE, AND NOT USABLE TO DILATE THE VEIN. A NEW DILATOR WAS USED TO DILATE THE VEIN." FAULTY PRODUCT DID NOT REACH THE PATIENT, NO HARM WAS REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468132 ↗
• MalfunctionJul 10, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THE QUALITY OF THE DILATOR IN THE KITS CHANGED . IT IS NO LONGER AS "STIFF" AS IT ORIGINALLY WAS. THIS "BUCKLING" WAS OCCURRING QUITE FREQUENTLY, AND WE HAD TO ADAPT OUR DILATION TECHNIQUE TO ACCOMMODATE FOR IT (LARGER NICK IN THE SKIN, STRETCH AND PAUSE BEFORE CONTINUING, AND HOLDING MUCH CLOSER TO HUB OF DILATOR). MOST OFTEN, THE DILATOR WOULD JUST BUCKLE AND NOT CREATE THE ROUGH EDGE, BUT SOMETIMES IT CREATED THE ROUGH EDGE MAKING IT UNUSABLE. NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468114 ↗
• MalfunctionMay 9, 2024Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT DL PICC LINE WITH A LEAKING T LOCK ASSEMBLY. DEVICE WAS USED ON ONE PATIENT. NO HARM REPORTED. THE EVENT DID NOT INVOLVE AN URGENT OR LIFE-THREATENING SITUATION. THE LEAK WAS DISCOVERED WHEN I WAS FLUSHING THE LINE DURING INSERTION, THE EVENT DID NOT INTERRUPT TREATMENT AND NO SIGNS, SYMPTOMS OR COMPLICATIONS EXPERIENCE BY PATIENT. WE SECURED THE DEVICE WITH A STAT LOCK. THERE WAS NO PATIENT HARM NOTED DUE TO MY INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281152 ↗
• MalfunctionFeb 5, 2024Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER ¿I HAVE A DL PICC LINE WITH A LEAKING T LOCK ASSEMBLY THAT WAS USED ON A PATIENT. OCCURRED ON JANUARY 12, 2024. THERE WAS NO PATIENT HARM AND IT DID NOT INVOLVE AN URGENT OR LIFE-THREATENING SITUATION OR A DELAY IN TREATMENT. THE LEAK WAS DISCOVERED WHEN I PRIMED THE LINE. NO SIGNS, SYMPTOMS, OR COMPLICATIONS EXPERIENCED BY THE PATIENT. I DO NOT HAVE THE NAME OF THE PLANNED MEDICATIONS TO BE INFUSED. WE SECURED THE DEVICE WITH A STATLOCK. NO HARM NOTED DUE TO MY INTERVENTION.¿ NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18643850 ↗
• MalfunctionDec 13, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT CATHETER THAT LEAKED FROM THE RUBBER-STOPPER WHEN PICC LINE WAS BEING INSERTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320648 ↗
• MalfunctionOct 24, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT HAVE A DOUBLE LUMEN PICC LINE WITH A LEAKING T LOCK ASSEMBLY. THE PRODUCT WAS USED ON A PATIENT. NO PATIENT HARM REPORTED, NO SIGNS, SYMPTOMS OR COMPLICATIONS EXPERIENCE BY PATIENT. EVENT DID NOT INVOLVE AN URGENT OR LIFE-THREATENING SITUATION. THE LEAK WAS DISCOVERED WHEN I PRIMED THE LINE. THE EVENT DID NOT INTERRUPT TREATMENT. I DO NOT HAVE THE NAME OF PLANNED MEDICATIONS TO BE INFUSED. WE SECURED THE DEVICE WITH A STAT LOCK. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995690 ↗
• MalfunctionSep 26, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT A CATHETER LEAKED FROM THE RUBBER-STOPPER WHEN PICC LINE WAS BEING INSERTED. NO PATIENT HARM REPORTED. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821278 ↗
• MalfunctionSep 8, 2023Defective Component; Defective Component

  CUSTOMER REPORTED CATHETER THAT LEAKED FROM THE RUBBER-STOPPER WHEN PICC LINE WAS BEING INSERTED. ADDITIONAL INFORMATION PROVIDED (B)(6): THE CATHETER DID NOT BREAK. EVENT DID NOT INTERRUPT TREATMENT OR CAUSE CLINICALLY SIGNIFICANT DELAY TO TREATMENT. NO OTHER INFORMATION WAS PROVIDED. THERE WERE TWO SAMPLES RETURNED FOR INVESTIGATION, THIS FILE REPRESENTS THE FIRST RETURNED SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17708742 ↗
• MalfunctionSep 7, 2023Defective Component; Defective Component

  CUSTOMER REPORTED CATHETER THAT LEAKED FROM THE RUBBER-STOPPER WHEN PICC LINE WAS BEING INSERTED. ADDITIONAL INFORMATION PROVIDED JULY 5: THE CATHETER DID NOT BREAK. EVENT DID NOT INTERRUPT TREATMENT OR CAUSE CLINICALLY SIGNIFICANT DELAY TO TREATMENT. NO OTHER INFORMATION WAS PROVIDED. THERE WERE TWO SAMPLES RETURNED FOR INVESTIGATION, THIS FILE REPRESENTS THE FIRST RETURNED SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703485 ↗
• MalfunctionSep 7, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE A DL PICC LINE WITH A LEAKING T LOCK ASSEMBLY. THE EVENT DID NOT INVOLVE AN URGENT OR LIFE-THREATENING SITUATION. THE LEAK WAS DISCOVERED WHEN CUSTOMER PRIMED THE LINE. THE EVENT DID NOT INTERRUPT TREATMENT AND NO SIGNS, SYMPTOMS, HARM OR COMPLICATIONS EXPERIENCE BY PATIENT. CUSTOMER SECURED THE DEVICE WITH A STAT LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17700993 ↗
• MalfunctionSep 7, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE A DL PICC LINE WITH A LEAKING T LOCK ASSEMBLY. THE INCIDENT OCCURRED (B)(6) 2023 WHEN THE PRODUCT WAS USED ON A PATIENT. THE LEAK WAS DISCOVERED WHEN THE LINE WAS PRIMED. THE DEVICE WAS SECURED WITH A STATLOCK. THE EVENT DID NOT INVOLVE AN URGENT OR LIFE THREATENING SITUATION AND THERE WAS NO HARM REPORTED. NO TREATMENT WAS INTERRUPTED, NO COMPLICATIONS OR SYMPTOMS EXPERIENCED BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17697897 ↗
• MalfunctionSep 1, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT ANOTHER DOUBLE LUMEN PICC LINE WITH A LEAKING T LOCK ASSEMBLY, THE LEAK WAS DISCOVERED WHEN WE PRIMED THE LINE. THE EVENT DID NOT INTERRUPT TREATMENT. SECURED THE DEVICE WITH A STAT LOCK. THE EVENT DID NOT INVOLVE AN URGENT OR LIFE-THREATENING SITUATION. THERE WAS NO PATIENT HARM NOTED DUE TO INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17673621 ↗
• MalfunctionAug 28, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT DL PICC LINE WITH A LEAKING T LOCK ASSEMBLY. IT WAS USED ON ONE PATIENT. OCCURRED (B)(6) 2023. THE PRODUCT WAS USED ON A PATIENT. NO HARM REPORTED. NO PATIENT INFORMATION AVAILABLE. THE EVENT DID NOT INVOLVE AN URGENT OR LIFE-THREATENING SITUATION. THE LEAK WAS DISCOVERED WHEN THEY PRIMED THE LINE. THE EVENT DID NOT INTERRUPT TREATMENT. NO SIGNS, SYMPTOMS OR COMPLICATIONS EXPERIENCE BY PATIENT. THEY DO NOT HAVE THE NAME OF PLANNED MEDICATIONS TO BE INFUSED. THEY SECURED THE DEVICE WITH A STAT LOCK. THERE WAS NO PATIENT HARM NOTED DUE TO THEIR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638808 ↗
• InjuryAug 14, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT AFTER ACCESS DURING A PICC PROCEDURE, NURSE FELT RESISTANCE WHEN ADVANCING THE GUIDEWIRE INTO THE PATIENT¿S VESSEL. THE NURSE WITHDREW THE GUIDEWIRE AND LEFT ACCESS NEEDLE IN PLACE AND REASSESSED VESSEL. AFTER VESSEL ASSESSMENT, NURSE REINSERTED GUIDEWIRE INTO PATIENT¿S VESSEL AND CONTINUED TO FEEL RESISTANCE AND WITHDREW AGAIN. ABOUT 2 CM OF THE TIP OF THE GUIDEWIRE WAS DISLODGED INTO THE PATIENT¿S ANATOMY. WHEN EVALUATING GUIDEWIRE AFTER ATTEMPTED INSERTION, NURSE NOTICED THE TIP OF THE GUIDE WIRE UNRAVELED. NO OTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION RECEIVED: NURSE WAS ADVISED TO REMOVE GUIDEWIRE AND NEEDLE AS A UNIT WHEN GUIDEWIRE NEEDS TO BE REMOVED FROM PATIENT PER IFU.

  Patient problems: Foreign Body In Patient

  MAUDE report 17547048 ↗
• MalfunctionAug 9, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THE CATHETER LEAKED FROM THE RUBBER-STOPPER WHEN PICC LINE WAS BEING INSERTED. NO PATIENT HARM. RESPONSE RECEIVED 26 JULY 2023: THE EVENT DID NOT INVOLVE AN URGENT OR LIFE THREATENING MEDICAL SITUATION, AND THERE WAS NO INTERRUPTION IN TREATMENT. THE DEVICE WAS SECURED WITH A STATLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17492115 ↗
• MalfunctionAug 2, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THE CATHETER LEAKED FROM THE RUBBER-STOPPER WHEN PICC LINE WAS BEING INSERTED. NO PATIENT HARM. NO OTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION RECEIVED 26 JULY 2023: NO URGENT/LIFE THREATENING MEDICAL SITUATION. DID NOT INTERRUPT TREATMENT, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN TREATMENT, THAT NEGATIVELY IMPACTED THE PATIENT. STAT LOCK USED FOR CATHETER SECUREMENT. NO PATIENT HARM, INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17443403 ↗
• MalfunctionAug 2, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "PICC TEAM DISCOVERED KINKED 5F DUAL LUMEN PICC WHEN X RAY OF PATIENTS ARM AFTER FLOOR NURSE COULD NOT FLUSH LINE". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17439851 ↗
• MalfunctionAug 1, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE DL PICC LINE WITH A LEAKING T LOCK ASSEMBLY. IT WAS USED ON ONE PATIENT. THERE WAS NO HARM REPORTED. THE EVENT DID NOT INVOLVE AN URGENT OR LIFE THREATENING SITUATION. THE LEAK WAS DISCOVERED WHEN THE CLINICIAN PRIMED THE LINE. THE EVENT DID NOT INTERRUPT TREATMENT. NO SIGNS, SYMPTOMS OR COMPLICATIONS EXPERIENCE BY PATIENT. CLINICIAN DO NOT HAVE THE NAME OF PLANNED MEDICATIONS TO BE INFUSED. CATHETER WAS SECURED THE DEVICE WITH A STATLOCK. THERE WAS NO PATIENT HARM NOTED DUE TO CLINICIAN INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17437135 ↗
• MalfunctionJul 31, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT CATHETER LEAKED FROM THE RUBBER-STOPPER WHEN PICC LINE WAS BEING INSERTED. ADDITIONAL INFORMATION RECEIVED ON 17 JULY 2023: LEAK DISCOVERED DURING INSERTION. CATHETER SECUREMENT WAS STAT LOCK. IT WAS STATED THE EVENT DID NOT INVOLVE AN URGENT OR LIFE THREATENING MEDICAL SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424298 ↗
• MalfunctionJul 25, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THE CATHETER THAT LEAKED FROM THE RUBBER-STOPPER WHEN PICC LINE WAS BEING INSERTED. ADDITIONAL INFORMATION FROM CUSTOMER ON 07-12-2023. THIS EVENT DID NOT INVOLVE A LIFE THREATENING SITUATION. THE LEAK WAS DISCOVERED DURING INSERTION. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389896 ↗