PowerPICC Provena S1193108D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741155086), received between Apr 9, 2021 and Mar 18, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 21, 2026Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Component Incompatible; Activation Problem

  IT WAS REPORTED THAT PICC TEAM MEMBER WAS PLACING A PICC LINE. USED THE GREEN INTRODUCER TO GAIN ACCESS. PUT THE WIRE DOWN THE INTRODUCER AND IT WENT SMOOTH. WHEN HE WENT TO SAFETY THE INTRODUCER, THE WIRE CAME OUT WITH IT. NO FURTHER DETAILS PROVIDED.

  Patient problems: Unintended Loss of Vascular Access

  MAUDE report 24625872 ↗
• MalfunctionDec 10, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED TODAY 11/22 WE WERE PLACING A 3FR SINGLE LUMEN PICC, WE ENCOUNTERED AN ISSUE WITH THE SHERLOCK. THERE WAS AN INTERMITTENT LOSS OF THE INTRAVASCULAR ECG LINE AKA THE "YELLOW" LINE (USED TO VERIFY PICC PLACEMENT) THAT PERSISTED DESPITE TROUBLE SHOOTING EFFORTS WHICH INCLUDED CHANGING OUT THE FIN ASSEMBLY AND THE ELECTRODES. THROUGH TRIAL AND ERROR, IT WAS DETERMINED THAT THIS ISSUE STOPPED WHEN WE TRADED OUT THE INTERNAL PICC GUIDEWIRE IN A NEW TRIPLE LUMEN PICC KIT. WE WERE ABLE TO AVOID A CXR IN THE PATIENT AND PREVENT DELAY OF CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768123 ↗
• MalfunctionDec 10, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED LAST NIGHT (11/21) AS WE WERE PLACING A 3FR SINGLE LUMEN PICC IN A PATIENT, WE ENCOUNTERED AN ISSUE WITH THE SHERLOCK. THERE WAS AN INTERMITTENT LOSS OF THE INTRAVASCULAR ECG LINE AKA THE "YELLOW" LINE (USED TO VERIFY PICC PLACEMENT) THAT PERSISTED DESPITE TROUBLE SHOOTING EFFORTS WHICH INCLUDED CHANGING OUT THE FIN ASSEMBLY AND THE ELECTRODES. ULTIMATELY PICC TIP VERIFICATION WAS DETERMINED USING CXR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768121 ↗
• MalfunctionAug 3, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT "SALINE LEAKS FROM T LOCK AREA ECG AND SEPTUM AREA. WE NOTICED THAT WHEN WE WENT TO FLUSH THE PICC LINE, THE FLUSH WOULD COME OUT AROUND THE WIRE ON THE END CAP INSTEAD OF FLUSHING THE LINE. WE HAVE NOTICED THIS ON MANY PICC LINES. WE WOULD PUT OUR FINGER OVER THE END CAP TO FLUSH." ADDITIONAL INFORMATION FROM CUSTOMER RESPONSE ON (B)(6) 2023. "THIS HAPPENED ON ALMOST EVERY PICC WE USED. IT WAS NOTED BEFORE AND DURING USE. NO PT INVOLVEMENT. NO SERIOUS INJURY TO ANYONE INVOLVED. THIS WAS MORE OF A PAIN FOR THE INSERTER OF THE PICC. NO MEDICATION USED BESIDES NORMAL SALINE FLUSH WITH THE PROVIDED SYRINGES THAT COMES WITH THE PICC KIT. ALL THE PICCS WERE INSERTED AND WIRE WITH CAP DISCARDED." THE CUSTOMER REPORTED THIS OCCURRED WITH MANY PICC LINES HOWEVER THE EXACT QUANTITY WAS NOT PROVIDED TO BD FIELD ASSURANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455714 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER "TWO CASES OF DVTS ASSOCIATED WITH 3FR PROVENA PICC USE. THEY STATED THEY ARE UNSURE IF THE DEVICE IS CAUSING THE DVTS OR PATIENT FACTORS." NO OTHER INFORMATION WAS PROVIDED. THIS FILE ADDRESSES THE SECOND DVT CASE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15982526 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER "TWO CASES OF DVTS ASSOCIATED WITH 3FR PROVENA PICC USE. THEY STATED THEY ARE UNSURE IF THE DEVICE IS CAUSING THE DVTS OR PATIENT FACTORS." NO OTHER INFORMATION WAS PROVIDED. THIS FILE ADDRESSES THE FIRST DVT CASE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15978813 ↗
• MalfunctionOct 19, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "INTRODUCER COLLAPSING WHEN IN USE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633415 ↗
• MalfunctionAug 11, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "NOTICED A CHANGE WITH THE PEEL AWAY SHEATH CAUSING THE PLACER TO HAVE TO NICK THE SKIN. WHERE THEY RARELY HAD TO DO THAT IN THE PAST. THEY HAVE ALSO COMMUNICATED THAT THE PEEL AWAY SHEATH IS ACCORDIONING BACK ON ITSELF UPON INSERTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15207604 ↗
• MalfunctionJul 22, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT A WIRE BROKE OFF ON JUNE 27TH. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214445 ↗
• MalfunctionJul 22, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT A WIRE BROKE ON JUNE 27TH. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214420 ↗
• MalfunctionApr 9, 2021Material Deformation; Migration; Material Deformation; Migration

  IT WAS REPORTED PICC MIGRATED INTO JUGULAR, FLUSHED LINE AND PULLED BACK TO REPOSITION. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? BARD PICC STAT LOCK AND 3M TEGADERM IV ADVANCED SECUREMENT. PLACEMENT DATE: 1/20/21. EXPLANT DATE: IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11642451 ↗