PowerPICC Provena S1294108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00801741130373), received between May 7, 2020 and Jul 6, 2026 — classified as 10 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (9 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. May 21, 2026Class IIOpen, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2664-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Material Deformation

  IT WAS REPORTED DEFECTIVE INTRODUCER. NOT USED ON PATIENT, OUT OF THE PACKAGE WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED. 06/18/2026 IT WAS FOUND DURING AN INVESTIGATION MICROSCOPIC INSPECTION OF THE DEVICE FOUND BUCKLING OF THE SHEATH EDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25719125 ↗
• MalfunctionMar 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT ONE OF THE LUMENS LEAKED WITH PRESSURE. PATIENT HAD NOT BEEN TO CTG AND NO CONTRAST HAD BEEN PULLED THROUGH. IN THE PATIENT FOR 4 DAYS BEFORE LEAKING OCCURRED. NURSE WENT IN TO CHECK ON PATIENT AND THE DRESSING WAS WET. NO SWELLING ON THE PATIENT. COULD ASPIRATE, BUT FLUID CAME OUT WHEN FLUSHING. CHEMO MEDS, BUT NOT A VESICANT, SO NO HARM TO THE PATIENT. NEW LINE PUT IN. NOT SURE WHERE ON THE LINE THE LEAK WAS COMING FROM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706276 ↗
• MalfunctionJun 10, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED BY THE CUSTOMER MORE FORCE AND MANIPULATION THAT USUAL WAS NEEDED TO BREAK THE INTRODUCER AWAY FROM THE LINE, PROLONGING THE INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179581 ↗
• InjuryFeb 5, 2025Material Frayed; Material Frayed

  IT WAS REPORTED BY MEDWATCH A PORTION OF THE PICC/GUIDEWIRE BROKE OFF AND WAS RETAINED IN THE PATIENT WHEN THE PICC /GUIDEWIRE WAS REMOVED FROM THE PATIENT. CONFIRMED 13MM RADIOPAQUE FOREIGN BODY STRUCTURE OVERLYING THE RIGHT AXILLARY REGION SUGGESTIVE OF A FOREIGN BODY FRAGMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21317122 ↗
• MalfunctionFeb 5, 2025Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH THAT PICC/GUIDEWIRE BROKE OFF AND WAS RETAINED IN THE PATIENT WHEN THE PICC WAS REMOVED FROM THE PATIENT. CONFIRMED 13MM RADIOPAQUE FOREIGN BODY STRUCTURE OVERLYING THE RIGHT AXILLARY REGION SUGGESTIVE OF A FOREIGN BODY FRAGMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21312160 ↗
• MalfunctionJan 20, 2025Material Frayed; Material Frayed

  IT WAS REPORTED STYLET BROKE OFF IN PATIENT UPON INSERTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191454 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT 2 PATIENT INCIDENCES WITH A PICC. ON THE FIRST INCIDENT, AFTER FLUSHING THE LINE, PATIENT COUGHED, IMPENDING DOOM, DROPPED HER PRESSURES AND STATS. ENDED UP IN THE ICU FOR O2 SUPPORT, BENADRYL, EPI PEN, AND SOLUMEDROL ADMINISTRATION. ON THE SECOND INCIDENT EACH LUMEN WAS FLUSHED WITH 10 ML SALINE, AFTER THE LINE WAS TRIMMED, THE LUMEN WAS FLUSHED WITH 10 ML. SAME REACTION, ENDED UP IN THE ICU. SECOND REACTION WAS REPORTED TO HAVE A DELAYED RESPONSE CAUSING RAPID RESPONSE ACTIVATION, AND O2 SUPPORT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST INCIDENT.

  Patient problems: Anaphylactoid / Anaphylaxis; Shock

  MAUDE report 20575396 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT ANXIOUS ABOUT INSERTION. 4FR DL PROVENA. PRE INSERTION, EACH LUMEN FLUSHED WITH 10 MLS. AND FLUSHED AGAIN AFTER THE LINE WAS TRIMMED. INSERTION SMOOTH. FLUSHED FOR ECG READING. ADJUSTED EACH LUMEN CHECKED FOR BLOOD RETURN AND FLUSHED THEN THE REACTION HAPPENED ¿ COUGH, UNUSUAL SENSATION IN STOMACH AND CHEST, PATIENT CYANOTIC, NON RESPONSIVE, SPONTANEOUSLY RETURNED TO BASELINE. REQUIRED RAPID RESPONSE ACTIVATION, O2 SUPPORT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Anaphylactoid / Anaphylaxis; Anxiety; Shock

  MAUDE report 20575389 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT 2 PATIENT INCIDENCES WITH A PICC. ON THE FIRST INCIDENT, AFTER FLUSHING THE LINE, PATIENT COUGHED, IMPENDING DOOM, DROPPED HER PRESSURES AND STATS. ENDED UP IN THE ICU FOR O2 SUPPORT, BENADRYL, EPI PEN, AND SOLUMEDROL ADMINISTRATION. ON THE SECOND INCIDENT EACH LUMEN WAS FLUSHED WITH 10 ML SALINE, AFTER THE LINE WAS TRIMMED, THE LUMEN WAS FLUSHED WITH 10 ML. SAME REACTION, ENDED UP IN THE ICU. SECOND REACTION WAS REPORTED TO HAVE A DELAYED RESPONSE CAUSING RAPID RESPONSE ACTIVATION, AND O2 SUPPORT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND INCIDENT.

  Patient problems: Anaphylactoid / Anaphylaxis; Shock

  MAUDE report 20575388 ↗
• MalfunctionJun 23, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  CUSTOMER REPORTED THAT THIS MICROINTRODUCER DID NOT PEEL AWAY PROPERLY AND THE SHEATH APPEARED TO BE NOT COMPLETELY CONNECTED TO THE HANDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17191227 ↗
• InjuryMay 26, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THE GUIDE WIRE BROKE OFF INSIDE PATIENT. NO OTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11890661 ↗
• InjuryMay 13, 2021Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "PIECE OF GUIDEWIRE BROKE OFF INSIDE PATIENT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11822190 ↗
• MalfunctionApr 19, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THE STYLET WAS KINKED IN A DOUBLE LUMEN PICC. IT WAS STATED THE WIRE BROKE OFF INSIDE THE BAG. THERE WAS NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686038 ↗
• MalfunctionApr 16, 2021Material Deformation; Material Deformation

  IT WAS REPORTED A DOUBLE LUMEN PICC STYLET WAS KINKED. IT WAS STATED THERE WAS NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679066 ↗
• MalfunctionApr 16, 2021Material Frayed; Material Deformation; Material Frayed; Material Deformation

  IT WAS REPORTED A DOUBLE LUMEN PICC STYLET WAS KINKED. IT WAS STATED THERE WAS NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679065 ↗
• MalfunctionApr 15, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "FRACTURED WIRE ON PICC INSERTION, PICC PLACEMENT WAS UNSUCCESSFUL" ADDITIONAL INFORMATION RECEIVED 03/28/2021: "THERE WAS NO HARM TO THE PATIENT". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675928 ↗
• InjuryApr 1, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT WHILE DOING AN X-RAY, THEY OBSERVED THAT A FRAGMENT OF THE WIRE WAS LEFT IN THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11603008 ↗
• InjuryMar 5, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED VIA MEDWATCH " ATTEMPTED TO INSERT A BARD PROVENA 4FR PICC CATHETER ON A PATIENT. THE SHERLOCK DEVICE WAS DETECTING SIGNAL WHILE THE PICC LINE WAS BEING ADVANCE INTO THE PATIENT. THE PICC TIP WAS FINALLY DETECTED AND IT SHOWED THAT IT WAS POINTING UP INTO THE PATIENTS'S (B)(6). NO RESISTANCE WAS FELT THROUGHOUT THE PROCEDURE. HOWEVER, WHEN THE PICC LINE WAS RETRACTED FOR REPOSITIONING A "CLICK" WAS FELT. THE PROCEDURE WAS THEN ABORTED, AND THE CATHETER WAS FOUND INTACT, BUT THE 3CG STYLET APPEARED TO BE SHEARED OFF. A CHEST X-RAY WAS IMMEDIATELY ORDERED AND FOUND 2CM PORTION OF THE 3CG STYLET IN THE PATIENT'S RIGHT VENTRICLE. "

  Patient problems: Foreign Body In Patient

  MAUDE report 11421676 ↗
• MalfunctionFeb 10, 2021Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED VIA MEDWATCH: "INSERTING PICC LINE INTO PATIENT USING 4FR BARD DOUBLE LUMEN PROVENA PICC. THE PICC 3CG LINE WOULD NOT ADVANCE DUE TO STYLET WIRE WAS FOUND TO BE BENT IN A SHARP ANGLE 4 CM FROM THE TOP."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11311384 ↗
• InjuryJan 21, 2021Break

  IT WAS REPORTED "CUSTOMER CALLED TO LET ME KNOW THAT A PORTION OF THE PICC STYLET BROKE OFF WHILE IN THE PATIENT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11207989 ↗
• InjuryJan 5, 2021Migration or Expulsion of Device; Material Separation; Migration or Expulsion of Device

  IT WAS REPORTED "DURING PICC INSERTION THE TIP OF THE 3CG POSITIONING WIRE BROKE OFF AND WAS RETAINED IN THE PATIENT. APPROXIMATELY 4CM OF THE TIP MIGRATED TO THE RIGHT PULMONARY ARTERY AND NEEDED TO BE RETRIEVED BY THE INTERVENTIONAL RADIOLOGY TEAM." PLACEMENT INFO: RUE. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: STATLOCK.

  Patient problems: Foreign Body In Patient

  MAUDE report 11118340 ↗
• MalfunctionOct 21, 2020Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PICC WAS NOTED TO BE KINKED WHICH CAUSED AN OCCLUSION IN THE CATHETER. IT WAS STATED THAT THE CATHETER WAS PLIABLE AND SOFT THAT IT FORMED WEAK SPOTS AND WOULDN'T FLUSH EVEN AFTER STRAIGHTENING OUT THE KINK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10715396 ↗
• MalfunctionOct 21, 2020Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PICC WAS NOTED TO BE KINKED WHICH CAUSED AN OCCLUSION IN THE CATHETER. IT WAS STATED THAT THE CATHETER WAS PLIABLE AND SOFT THAT IT FORMED WEAK SPOTS AND WOULDN'T FLUSH EVEN AFTER STRAIGHTENING OUT THE KINK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10715339 ↗
• MalfunctionOct 21, 2020Flushing Problem; Obstruction of Flow; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PICC WAS NOTED TO BE KINKED WHICH CAUSED AN OCCLUSION IN THE CATHETER. IT WAS STATED THAT THE CATHETER WAS PLIABLE AND SOFT THAT IT FORMED WEAK SPOTS AND WOULDN'T FLUSH EVEN AFTER STRAIGHTENING OUT THE KINK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10715337 ↗
• MalfunctionOct 21, 2020Flushing Problem; Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PICC WAS NOTED TO BE KINKED WHICH CAUSED AN OCCLUSION IN THE CATHETER. IT WAS STATED THAT THE CATHETER WAS PLIABLE AND SOFT THAT IT FORMED WEAK SPOTS AND WOULDN'T FLUSH EVEN AFTER STRAIGHTENING OUT THE KINK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10715279 ↗