PowerPICC Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet 1174108Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741034442), received between Dec 17, 2015 and Mar 5, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (5 reports).

1 FDA recall record name this device's identifier, 1 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, 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.

Recalls naming this device

1. Mar 11, 2025Class IOpen, Classified

   Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

   Z-1507-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, "THE VAD TEAM PLACED A 4 FR. SINGLE LUMEN BARD POWER PICC IN A PATIENT ON (B)(6) 2025. SHE WAS IN NEED OF 6 WEEKS OF IV ANTIBIOTICS. SHE THEN TRANSFERRED TO A DIFFERENT FACILITY FOR SKILLED NURSING AND IV ANTIBIOTIC THERAPY. WHILE THERE, THE VAD TEAM WAS CALLED TO ASSESS HER THIS PAST WEEKEND ON (B)(6) 2025. OUR STAFF ASSESSED HER AND THE PATIENT SAID THAT SHE FELT A BUBBLING SENSATION NEAR HER RIGHT COLLAR BONE. THE VAD TEAM PLACED A TEMPORARY IV FOR MEDICATION ADMINISTRATION AND RECOMMENDED THAT THE STAFF NOT USE THE PICC LINE AND THAT THE VAD TEAM WOULD FOLLOW UP MONDAY SINCE IR WOULD BE AVAILABLE, A PORTABLE CHEST XRAY WAS ALSO ORDERED. THE VAD TEAM EVALUATED THE PATIENT MONDAY ON (B)(6) 2025, THE XRAY DEMONSTRATED THAT THE PICC TIP WAS IN NORMAL POSITION WITHIN THE SVC AND THERE WAS NOTHING ABNORMAL ABOUT THE APPEARANCE OF THE CATHETER. I PHYSICALLY EVALUATED THE PATIENT AND FLUSHED THE LINE WITH 30 ML OF NORMAL SALINE, THE LINE FLUSHED EASILY HOWEVER I WAS NOT ABLE TO OBSERVE A BLOOD RETURN. AGAIN, THE PATIENT DESCRIBED A BUBBLING SENSATION IN THE AREA OF THE RIGHT CLAVICLE. I TOLD HER THAT I WOULD DISCUSS HER CARE FURTHER WITH THE PHYSICIANS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528275 ↗
• MalfunctionFeb 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THE CATHETER JUST HAD A SMALL HOLE EXTERNAL TO THE PATIENT. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21365117 ↗
• MalfunctionOct 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MS&S "NURSE STATES SHE HAS A PATIENT WITH A 4FR SL POWERPICC WHO SHE THINKS HAS DAMAGED THE CATHETER INTENTIONALLY. THE HOLE IS ON THE DISTAL END OF THE PLASTIC WINGED PORTION OF THE CATHETER BETWEEN THE WINGS AND GRADUATION MARK "0". THE HOLE APPEARS TO BE CIRCUMFERENTIAL ALONG THE BACK SIDE OF THE CATHETER. COULD THE CATHETER HAVE "BLOWN OUT" FROM TOO MUCH PRESSURE BEING INJECTED INTO THE PICC LINE? WHAT IS THE MAX PSI?" MS&S RESPONSE "INFORMED CALLER THAT PER THE POWERPICC IFU, "EXCEEDING THE MAXIMUM FLOW RATE OF 5 ML/SEC, OR THE MAXIMUM PRESSURE OF POWER INJECTORS OF 300 PSI, MAY RESULT IN CATHETER FAILURE AND/OR CATHETER TIP DISPLACEMENT". WE DO NOT HAVE INFORMATION ON WHERE THE CATHETER WOULD BE DAMAGED IF THE PSI EXCEEDED THE RECOMMENDATIONS OF THE IFU. PLEASE NOTE A FRACTURED PICC LINE CAN LEAD TO BLOOD LOSS OR OTHER COMPLICATIONS. THE PICC LINE WILL NEED TO BE REPLACED FOR USE AND ENSURE THE SAFETY OF THE PATIENT"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686946 ↗
• MalfunctionAug 6, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGING OF FIVE PICC KITS WERE WET. THIS REPORT ADDRESSES THE FIFTH KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291186 ↗
• MalfunctionAug 6, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGING OF FIVE PICC KITS WERE WET. THIS REPORT ADDRESSES THE FOURTH KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291178 ↗
• MalfunctionAug 6, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGING OF FIVE PICC KITS WERE WET. THIS REPORT ADDRESSES THE FIRST KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291172 ↗
• MalfunctionAug 6, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGING OF FIVE PICC KITS WERE WET. THIS REPORT ADDRESSES THE THIRD KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291169 ↗
• MalfunctionAug 6, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGING OF FIVE PICC KITS WERE WET. THIS REPORT ADDRESSES THE SECOND KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291167 ↗
• MalfunctionApr 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT OVER THE LAST MONTH THE FACILITY WAS HAVING ISSUES WITH THE MICROINTRODUCER FRAYING WHEN ATTEMPTING TO ADVANCE INTO THE VEIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11749487 ↗
• MalfunctionApr 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THE MICROINTRODUCER FRAYED WHEN ATTEMPTED TO ADVANCE IT TO THE VEIN. A NEW KIT WAS OPENED TO GET ANOTHER MICROINTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11749480 ↗
• MalfunctionApr 9, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED BY HEALTH PROFESSIONAL "I CAME ACROSS AN EXPIRED KIT. THE LOT # IS REDX3925 WITH AN EXPIRATION DATE OF (B)(6) 2020. IT'S ONE OF THE NEWER (THIN) KITS THAT JUST CAME RECENTLY. IT'S A 4 FRENCH SINGLE LUMEN PICC. " THE DEVICE WAS NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11645040 ↗
• MalfunctionJan 13, 2021Obstruction of Flow; Material Deformation

  IT WAS REPORTED "NURSE MET OBSTRUCTION, STYLET WOULD NOT COME OUT AND WHEN IT DID, WAS SNAKED/ DEFORMED WITH SMALL BENDS ABOUT ½ CM IN LENGTH." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11167577 ↗
• InjuryNov 20, 2018Break; Device Dislodged or Dislocated

  PER EMAIL: RECEIVED A PRODUCT COMPLAINT PERTAINING TO THE POWER PICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET. THE STYLET TIP BROKE OFF OF THE STYLET. IT WAS DISLODGED INTO THE PATIENT¿S ARM. NO OTHER DETAILS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8092586 ↗
• MalfunctionJan 7, 2016Fluid/Blood Leak; Flushing Problem; Hole In Material

  PER SALES REPRESENTATIVE, FACILITY REPORTED THAT A PATIENT CAME IN (B)(6) 2015 TO HAVE PICC LINE REMOVED. PATIENT STATED THAT HE WAS UNABLE TO FLUSH AND HOME CARE NURSE TOLD HIM TO PUSH HARD. PATIENT STATED HE HEARD A POP AND WHEN INFUSING MEDICATION, IT BURNED IN HIS ARM. UPON REMOVAL, THE CATHETER WAS FLUSHED AND A HOLE WAS NOTED.

  Patient problems: Burning Sensation

  MAUDE report 5352565 ↗
• MalfunctionDec 17, 2015Break; Detachment Of Device Component; Material Protrusion/Extrusion

  MEDWATCH REPORTED THAT, THE PICC WAS PREPARED IN THE USUAL FASHION AND CUT AT THE 46 CM MARK AFTER MAGNETIC TIPPED WIRE WAS WITHDRAWN SEVERAL CENTIMETERS BEFORE THAT MARK. THE SEVERED TIP WAS HANDED OFF TO THE 2ND PICC RN WHO VERIFIED THE LENGTH. THE PICC WAS INSERTED THROUGH THE DILATOR. THE DIRECTIONAL DEVICE INDICATED THE PICC TIP WAS GOING TOWARD THE NECK, INSTEAD OF THE CHEST. THE RN WAS GOING TO PULL WIRE BACK TO GIVE A SOFTER TIP WHEN SUPPOSEDLY, HE NOTICED HE HAD NEGLECTED TO BEND AND SECURE THE EXTERNAL PORTION OF THE WIRE. HE ASKED FOR ANOTHER PICC TO ENSURE SAFE PLACEMENT. REPORTEDLY, HE PULLED THE PICC OUT TO THE 16 CM MARK, REMOVED THE MAGNETIC TIPPED WIRE AND CUT THE LINE AT THE 16 CM MARK. HE THEN INSERTED THE GUIDEWIRE THROUGH THIS CUT PORTION AND PULLED THE LINE REMNANT OUT OF THE ARM OVER THE GUIDEWIRE. HE WAS HOLDING GAUZE ON THE INSERTION SITE AS HE PULLED IT OUT. ALLEGEDLY, WHEN HE LIFTED THE GAUZE, HE NOTICED A 2ND WIRE PROTRUDING FROM THE INSERTION SITE. HE PULLED THIS WIRE OUT AND IT WAS A PORTION OF A MAGNETIC WIRE ABOUT 5 CM IN LENGTH. WE CAN ONLY SURMISE THAT THIS SHORT SECTION MUST HAVE BEEN INSIDE THE REMNANT HE PULLED OUT. REPORTEDLY, WE ARE UNSURE HOW

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5308703 ↗