PowerPICC Provena S1193108D3Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741154980), received between Feb 12, 2020 and Dec 30, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED BY CUSTOMER THAT THEY HAVE A DEFECTIVE PICC THAT WE WERE HOPING TO GET REPLACED. THE TAPER STARTED AT THE 6CM MARK, SO IT WOULD NOT ADVANCE INTO THE SHEATH PAST THAT POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931578 ↗
• MalfunctionMar 30, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED, INVERTED P-WAVE / QRS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19009029 ↗
• MalfunctionJan 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "TWO MICROINTRODUCERS BENT WHEN TRYING TO INSERT." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE. 1/20/2023 - THE CUSTOMER REPORTED THIS EVENT OCCURRED ON TWO DEVICES HOWEVER ONLY RETURNED ONE DEVICE FOR EVALUATION. THIS FILE WILL ADDRESS THE DEVICE THAT WAS NOT RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250309 ↗
• MalfunctionJan 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "TWO MICROINTRODUCERS BENT WHEN TRYING TO INSERT." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE. ON (B)(6) 2023 - THE CUSTOMER REPORTED THIS EVENT OCCURRED ON TWO DEVICES HOWEVER ONLY RETURNED ONE DEVICE FOR EVALUATION. THIS FILE WILL ADDRESS THE RETURNED MICROINTRODUCER TIP THAT EXHIBITED A SECTION WITH INWARD BUNCHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16248339 ↗
• MalfunctionOct 12, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "THE PEEL AWAY SHEATH IS "SERIOUSLY HANGING UP IN SKIN". ONE OCCURRED ON (B)(6) 2022. IT WAS REPLACED WITH A DROP-IN MICROINTRODUCER KIT AND "WORKED LIKE A CHARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15589385 ↗
• MalfunctionFeb 23, 2021Device Markings/Labelling Problem; Naturally Worn

  IT WAS REPORTED THE PROVENA POWERPICCS THAT WE HAVE BEEN USING, IS THAT AFTER A FEW DRESSING CHANGES AND AFTER A FEW WEEKS, THE NUMBERS AND TICK MARKS ON THE OUTSIDE OF THE CATHETER START TO WEAR OFF. ADDITIONAL INFORMATION RECEIVED (B)(6) 2021: WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: STAT-LOCK. WAS THERE PATIENT HARM REPORTED?: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11369265 ↗
• MalfunctionFeb 12, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT "ON (B)(6) 2020 THE OPERATOR INVOLVED IN A PICC LINE INSERTION UTILIZING SHERLOCK 3CG GUIDANCE. THE OPERATOR INDICATES THAT HE GAINED VASCULAR ACCESS, TRIMMED THE PICC AND WAS INSERTING UNDER SHERLOCK 3CG GUIDANCE WITH NORMAL TRACKING INDICATED. THE OPERATOR INDICATES THE PICC APPEARED TO BE ALMOST FULLY INSERTED WHEN RESISTANCE WAS FELT AND SHERLOCK TRACKING INDICATED POSSIBLE ¿LOOPING¿ OF CATHETER. THE OPERATOR FLUSHED THE PICC BRISKLY WITH SALINE AND THE ¿LOOP APPEARED TO RESOLVE¿. FINAL TIP LOCATION WAS CONFIRMED UTILIZING 3CG WITH MAX P-WAVE NOTED. UPON REMOVAL OF THE STYLETTE AT THE END OF THE PROCEDURE THE OPERATOR NOTICED A ¿KINK¿ IN THE STYLETTE 5 CM PROXIMAL TO THE NITINOL STYLETTE TIP. THE OPERATOR REPORTS THAT THE STYLETTE WAS INTACT AND THE PROCEDURE WAS COMPLETED WITH THE PICC LEFT IN PLACE. THE OPERATOR DID NOT RETAIN THE STYLETTE OR ANY OTHER COMPONENTS FOR EVALUATION."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700619 ↗