PowerPICC Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet 1385108QDRecalls & reported problems
Bard Access Systems, Inc. · PowerPICC HF Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet 5F Maximal Barrier Tray · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard PowerPICC catheter appears in 89 adverse event reports, with no deaths and 8 injuries. Many reports describe fluid or blood leaking from the line, along with kinks, holes or slits, and lumens tearing. Some reports list bleeding. There were 6 reports in the past 12 months, down from 18 in the year before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 88
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 00801741034657), received between Dec 21, 2015 and Feb 27, 2026 — classified as 8 injuries, 80 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (31 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak31
- Material Deformation17
- Break10
- Defective Component4
- Hole In Material3
- Leak/Splash3
- Material Frayed3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Consequences Or Impact To Patient22
- No Known Impact Or Consequence To Patient16
- Hemorrhage/Blood Loss/Bleeding2
- Infiltration into Tissue2
- Needle Stick/Puncture2
- Device Embedded In Tissue or Plaque1
- Discomfort1
Recent adverse event reports
The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Fluid/Blood Leak
IT WAS REPORTED THAT HEARD AIR/KIND OF WHISTLED WHEN FLUSHING GREY LUMEN OF PICC. AFTER REMOVAL THERE IS A HOLE BETWEEN THE 3 AND 4CM MARKS. NEW LINE INSERTED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24472212 ↗MalfunctionFeb 5, 2026Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT ISSUE WITH FLEXIBILITY OF PICC, AFTER PLACEMENT IN THE PATIENT, KINKING OF THE CATHETER OCCURRED. NO HARM TO PATIENT. IT WAS REPORTED THIS OCCURRED WITH 6 DEVICES. THIS REPORT ADDRESSES ALL 6 DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24269364 ↗MalfunctionJan 28, 2026Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT THERE WAS A SLIT AT THE 1-2CM MARK IN THE TL PICC. CATHETER WAS SECURED WITH STATLOCK. INSERTED (B)(6) 2025, REMOVED (B)(6) 2025. CATHETER WAS USED FOR TPN. PICC REMOVED. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202222 ↗MalfunctionJan 28, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A SLIT AT THE 1-2CM MARK IN THE TL PICC. CATHETER WAS SECURED WITH STATLOCK. INSERTED (B)(6) 2026, REMOVED (B)(6) 2026. CATHETER WAS USED FOR TPN. PICC EXCHANGED IN VIR. NO FURTHER DETAILS AVAILABLE OR PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202220 ↗MalfunctionJan 27, 2026Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT THERE WAS A SLIT AT THE 1-2CM MARK IN THE TL PICC. CATHETER WAS SECURED WITH STATLOCK. INSERTED (B)(6) 2025, REMOVED (B)(6) 2025. CATHETER WAS USED FOR TPN. PICC EXCHANGED IN VIR. NO FURTHER DETAILS AVAILABLE OR PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24195963 ↗MalfunctionJun 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED; PATIENT ARRIVED FOR IVIG INFUSION. THERE WAS SOME LEAKING AT GREY LUMEN OF PICC LINE PRIOR TO PATIENT ARRIVING FOR HER APPT. ON ARRIVAL LINE WAS FLUSHED WITH NOTICEABLE DRAINAGE AT THE HUB. IV RN CAME TO ASSESS PICC LINE AND DETERMINED THAT LINE SHOULD BE REMOVED. LINE WAS REMOVED. NO HARM TO PATIENT OR CLINICAL STAFF. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22127483 ↗MalfunctionJun 2, 2025Material Deformation; Material Deformation
IT WAS REPORTED, PICC CATHETER WITH A KINK. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22127481 ↗MalfunctionFeb 5, 2025Material Deformation; Material Deformation
IT WAS REPORTED THE PICC KINKED AT APPROXIMATELY 40CM DEPTH MARK IN THE INNOMINATE REGION 8 DAYS AFTER INSERTION. THE CATHETER WAS INSERTED (B)(6) 2024 WITH 46 CM TOTAL LENGTH, 0CM EXTERNAL AND SECURED WITH STATLOCK. CATHETER DID NOT REQUIRE TPA DURING DWELL PERIOD. CATHETER WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313966 ↗MalfunctionFeb 5, 2025Material Deformation; Material Deformation
IT WAS REPORTED THE PICC KINKED AT APPROXIMATELY THE 2CM DEPTH MARK NEAR THE INSERTION SITE 11 DAYS AFTER INSERTION. CATHETER WAS INSERTED ON (B)(6) 2024 IN THE LEFT UPPER EXTREMITY WITH 46CM TOTAL LENGTH, 3CM EXTERNAL AND SECURED WITH STATLOCK. CATHETER DID NOT REQUIRE TPA DURING DWELL PERIOD. CATHETER WAS PULLED BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313965 ↗MalfunctionFeb 5, 2025Material Deformation; Material Deformation
CUSTOMER REPORTED A PICC KINKED AT APPROXIMATELY THE 3CM DEPTH MARK NEAR THE INSERTION SITE 13 DAYS AFTER INSERTION. THE PICC WAS INSERTED ON (B)(6) 2024 IN THE LUE, WITH 55CM TOTAL LENGTH AND 4CM LEFT EXTERNAL, SECURED WITH STATLOCK. THE CATHETER HAD NOT REQUIRED TPA DURING THE DWELL PERIOD. PICC WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313963 ↗MalfunctionFeb 5, 2025Material Deformation; Material Deformation
CUSTOMER REPORTED A PICC KINKED AT APPROXIMATELY THE 6CM DEPTH MARK IN THE MIDDLE 1/3 OF THE UPPER EXTREMITY 12 DAYS AFTER INSERTION. PICC WAS PLACED IN THE RUE ON (B)(6)2024 WITH 38CM TOTAL LENGTH AND 2CM LEFT EXTERNAL TO THE PATIENT. CATHETER SECURED WITH STATLOCK. CATHETER HAD BEEN TPA'D ONCE DURING THE INDWELL PERIOD. PICC WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313961 ↗MalfunctionFeb 5, 2025Material Deformation; Material Deformation
CUSTOMER REPORTED A PICC KINKED AT APPROXIMATELY THE 4CM DEPTH MARK IN THE MIDDLE 1/3 OF THE UPPER EXTREMITY 10 DAYS AFTER INSERTION. CATHETER WAS INSERTED ON (B)(6) 2024 WITH 40CM TOTAL LENGTH AND 0CM LEFT EXTERNAL TO THE PATIENT, SECURED WITH STATLOCK. THE CATHETER DID NOT REQUIRE TPA DURING THE DWELL PERIOD. CATHETER WAS PULLED BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313960 ↗MalfunctionFeb 5, 2025Material Deformation; Material Deformation
IT WAS REPORTED THE PICC KINKED AT APPROXIMATELY THE 30CM DEPTH MARK IN THE SUBCLAVIAN AREA 2 DAYS AFTER INSERTION. THE CATHETER WAS INSERTED ON (B)(6) 2024 WITH 39 CM TOTAL LENGTH AND 0CM LEFT EXTERNAL, SECURED WITH STATLOCK. THE PICC DID NOT REQUIRE TPA DURING THE DWELL PERIOD. PICC WAS EXCHANGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313959 ↗MalfunctionJan 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED BY CUSTOMER THAT PICC PLACED 12/04, ON 12/12 PICC MALPOSITION LOOPED IN THE BRACHIOCEPHALIC. XRAY IMAGING TAKEN. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21146633 ↗MalfunctionJan 14, 2025Material Deformation; Material Deformation
IT WAS REPORTED, PICC PLACED (B)(6) 2024. ON (B)(6) 2024 HUMERUS X-RAY SHOWED CATHETER KINKED. PICC PULLED BACK. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21146558 ↗MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED VIA MEDSUN, FRACTURED PICC AT 1CM MARK, PICC REPLACED (B)(6) 2024. INITIAL PICC WAS SECURED WITH SECURACATH. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21121153 ↗MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A PICC WAS PLACED ON 10/31/2024 MEASURING AT 45 CM WITH 2 CM VISIBLE WITH SECUREMENT DEVICE USED TO KEEP THE PICC IN PLACE. ON 11/8/2024 THE PICC WAS FOUND TO BE LEAKING PICC WAS REMOVED, WITH NEW PERIPHERAL IV PLACED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21121104 ↗MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED PICC FRACTURED AND LEAKING AT 0 CM MARK. INSERTED ON (B)(6) 2024 AND DWELLED FOR 17 DAYS. SECUREACATH USED, TOTAL LENGTH 45 CM, EXIT SITE MARKING 3 CM. A NEW PICC WAS INSERTED ON (B)(6) 2024. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21120807 ↗MalfunctionJan 4, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT A PICC KINKED. PICC WAS INSERTED IN THE RIGHT BASILIC VEIN WITH 41CM TOTAL LENGTH AND 0CM LEFT EXTERNAL. THE DEVICE WAS INDWELLING FOR 46 DAYS AND KINKED IN THE MIDDLE 1/3 OF THE UPPER EXTREMITY. PICC WAS REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21075664 ↗MalfunctionJan 4, 2025Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT 15 PICCS KINKED. TPA WAS USED IN 8 PICCS. PICC DWELL TIME IN PATIENTS RANGED FROM 1 TO 30 DAYS. PICCS WERE REPOSITIONED, REMOVED AND/OR REPLACED WITH 1 REQUIRING A REFERRAL TO INTERVENTIONAL RADIOLOGY (IR). THIS REPORT ADDRESSES ALL 15 DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21075639 ↗MalfunctionDec 4, 2024Activation Problem; Activation Problem
IT WAS REPORTED THERE HAVE BEEN TWO OCCURRENCES IN THE MONTH OF OCTOBER WHERE THE GREEN SAFETY ON THE INTRODUCER NEEDLE IN THE KIT HAS FALLEN OFF, NOT MAKING THE DEVICE A SAFETY DEVICE. NO INJURIES REPORTED. THIS REPORT ADDRESSES BOTH DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20849857 ↗MalfunctionDec 1, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WE HAD A PICC PRODUCT FAILURE . WHILE THREADING IT DURING INSERTION AND FLUSHING/CHECKING FOR BLOOD RETURN, THE GRAY LUMEN WAS FOUND TO BE LEAKING BETWEEN THE 0.5 CM MARK NEAR THE HUB. DATE DISCOVERED (LEAKING): (B)(6) 2024. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20815503 ↗MalfunctionNov 24, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT WHILE THREADING DURING INSERTION AND FLUSHING/CHECKING FOR BLOOD RETURN, THE GRAY LUMEN WAS FOUND TO BE LEAKING BETWEEN THE 0-1CM MARK NEAR THE HUB. PATIENT IMPACT: UNNECESSARY PROCEDURE/ PREMATURE REPLACEMENT VIA PICC EXCHANGE. NO OTHER INFORMATION PROVIDED, AT THIS TIME. IT WAS REPORTED THIS OCCURRED WITH 2 DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20767750 ↗MalfunctionOct 30, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER CLINICIAN SUSPECTS THAT A CRACK DEVELOPED IN AN INDWELLING PICC CATHETER AS SALINE LEAKS FROM INSERTION SITE UPON FLUSHING GRAY SPOT. TRIPLE LUMEN PICC HAD DWELLED FOR 13 DAYS AND WAS STABILIZED AT THE TIME OF INSERTION USING SECREUACATH DEVICE. NO HARM OR PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20569243 ↗InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY CUSTOMER THAT AN ASSOCIATE HAD AN INJURY INVOLVING A BLOODBORNE EXPOSURE FROM THEM CUTTING THEMSELVES WITH A SCALPEL WHILE ATTEMPTING TO TRIM THE LINE. THE SAME SCALPEL THAT WAS USED ON THE PATIENT WAS UTILIZED BY MISTAKE TO TRIM THE LINE AT WHICH TIME THE ASSOCIATE ACCIDENTLY CUT THEMSELVES. THE KIT BEING UTILIZED WAS FROM A KIT THAT CONTAINED DOUBLE SCALPEL BLADES INSTEAD OF THE SCISSORS OR GUILLOTINE DEVICE. COULD YOU PROVIDE ME INFORMATION ON WHY SOME KITS ARE BEING SENT WITH DOUBLE SCALPELS INSTEAD OF THE SCISSORS OR GUILLOTINE DEVICES? NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Needle Stick/Puncture
MAUDE report 20418112 ↗
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- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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