PowerPICC Provena S9274108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00801741130441), received between Sep 21, 2017 and Jul 12, 2023 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT APPROXIMATELY 3 CM OF THE TIP OF THE GUIDEWIRE BROKE OFF DURING A PICC PLACEMENT AND REQUIRED INTERVENTIONAL RADIOLOGY TO RETRIEVE THE BROKEN PORTION OF THE WIRE. ADDITIONAL INFO FROM CUSTOMER: 10-JULY-2023: CUSTOMER REPORTED "BROKEN GUIDEWIRE LEFT IN PATIENT THAT MIGRATED TO PULMONARY ARTERY. PATIENT TAKEN TO INTERVENTIONAL RADIOLOGY WHEN RADIOLOGIST ATTEMPTED TO REMOVE BROKEN WIRE. IN THE PROCESS OF ATTEMPTING RETRIEVAL, PATIENT'S AICD LEAD WAS DISLODGED CAUSING, PATIENT TO BECOME HEMODYNAMICALLY UNSTABLE. AT THIS TIME, MEDICATION WAS ADMINISTERED TO IMPROVE HEART RATE AND BLOOD PRESSURE. IN ADDITION, A TEMPORARY CARDIAC PACEMAKER HAD TO BE PLACED EMERGENTLY. A SECOND ATTEMPT WAS MADE 2 DAYS LATER AND BROKEN WIRE WAS SUCCESSFULLY RETRIEVED."

  Patient problems: Foreign Body In Patient

  MAUDE report 17313098 ↗
• InjuryJun 10, 2023Material Frayed; Material Frayed

  THE CUSTOMER REPORTED A GUIDEWIRE TIP BREAK OFF DURING A PICC INSERTION WITH ABOUT 1.5 CM OF IT REMAINING IN THE PATIENT. THE CLINICIAN WHO PLACED THE LINE STATED THAT IT WAS A SMOOTH INSERTION, THEY MET RESISTANCE ONCE PULLED BACK AND WERE ABLE TO THREAD THE PICC WITHOUT ANY FURTHER RESISTANCE. THEY DID NOT DISCOVER THE WIRE TIP HAD BROKEN OFF UNTIL DAYS LATER AND THE WIRE WAS ALREADY DISCHARGED. WIRE MADE ITS WAY TO PATIENT'S LUNG. THEY WENT IN YESTERDAY TO RETRIEVE THE WIRE AND WERE UNSUCCESSFUL. DURING THE RETRIEVAL PROCESS THE PATIENT CODED. AT THIS POINT THEY ARE STILL DETERMINING THE BEST COURSE OF ACTION FOR THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest

  MAUDE report 17102116 ↗
• MalfunctionOct 12, 2022Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THAT "THEY HAD A TLS PICC STYLET BREAK DURING INSERTION. BOTH PIECES WERE ABLE TO BE REMOVED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587534 ↗
• MalfunctionJul 16, 2021Material Deformation; Material Deformation

  IT WAS REPORTED "PRODUCT COMPLAINT". ADDITIONAL INFORMATION RECEIVED 06/28/2021: "ADMISSION OF 6/8-6/22 THREE CALLS FOR NO BLOOD RETURN; TPA INSTALLATION X2: PICC PULLED BACK X2 TO ESTABLISH BLOOD RETURN. ORIGINAL EXTERNAL 2 CM. PULLED BACK TO 6 CM AS KINK WAS FOUND AT APPROX 5CM. REMOVED ON (B)(6) AS TREATMENT COMPLETE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12182125 ↗
• MalfunctionNov 12, 2020Material Twisted/Bent

  IT WAS REPORTED "AT LEAST 4 PATIENTS RECENTLY THAT HAVE PICCS THAT KINK RIGHT AT THE BEGINNING OF THE CATHETER. CUSTOMER FEELS SHE HAS HAD MULTIPLE PICCS KINK LATELY AT THE INSERTION SITE." THIS REPORT ADDRESSES THE FOURTH PATIENT WITH A KINKED CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10829725 ↗
• MalfunctionNov 12, 2020Material Deformation

  IT WAS REPORTED "AT LEAST 4 PATIENTS RECENTLY THAT HAVE PICCS THAT KINK RIGHT AT THE BEGINNING OF THE CATHETER. CUSTOMER FEELS SHE HAS HAD MULTIPLE PICCS KINK LATELY AT THE INSERTION SITE." THIS REPORT ADDRESSES THE THIRD PATIENT WITH A KINKED CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10829724 ↗
• MalfunctionNov 12, 2020Material Deformation

  IT WAS REPORTED "AT LEAST 4 PATIENTS RECENTLY THAT HAVE PICCS THAT KINK RIGHT AT THE BEGINNING OF THE CATHETER. CUSTOMER FEELS SHE HAS HAD MULTIPLE PICCS KINK LATELY AT THE INSERTION SITE." THIS REPORT ADDRESSES THE SECOND PATIENT WITH A KINKED CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10829717 ↗
• MalfunctionNov 12, 2020Material Twisted/Bent

  IT WAS REPORTED "AT LEAST 4 PATIENTS RECENTLY THAT HAVE PICCS THAT KINK RIGHT AT THE BEGINNING OF THE CATHETER. CUSTOMER FEELS SHE HAS HAD MULTIPLE PICCS KINK LATELY AT THE INSERTION SITE." THIS REPORT ADDRESSES THE FIRST PATIENT WITH A KINKED CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10829713 ↗
• MalfunctionApr 23, 2018Break; Detachment Of Device Component; Nonstandard Device

  THE FACILITY REPORTED TO THE SALES REP THAT THE HUB BROKE OFF OF THE PROVENA PICC. NO PATIENT INJURY WAS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7450677 ↗
• MalfunctionApr 19, 2018Leak/Splash; Nonstandard Device

  IT WAS REPORTED THAT THERE WAS A LEAK AT THE JUNCTION BETWEEN THE PURPLE LUMEN AND THE TUBING WITH THE CLAMP. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7445547 ↗
• MalfunctionApr 6, 2018Disconnection; Component Missing

  IT WAS REPORTED THAT A HOMECARE PATIENT THAT HAD A 4FR. PROVENA PICC CAME IN AND BOTH HUB AND CLAVE'S WERE MISSING; THE LINES WERE CLAMPED BUT HUB'S AND CLAVE'S HAD APPARENTLY DISCONNECTED FROM THE TUBING. THE PICC WAS REPLACED IN THE ED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7403752 ↗
• MalfunctionMar 19, 2018Obstruction of Flow

  THE FACILITY REPORTED THAT THE 4FR D/L CATHETERS ARE CLOTTING OFF EASILY ESPECIALLY WITH CANCER PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombus

  MAUDE report 7351004 ↗
• MalfunctionMar 19, 2018Detachment Of Device Component

  THE FACILITY REPORTED THAT THE PATIENT'S LINE WAS PLACED ON (B)(6) 2018. IT WAS STATED THAT THE PURPLE PORT COMPLETELY SLID OFF THE LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7350178 ↗
• MalfunctionDec 20, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC WAS LEAKING AT THE RED HUB AND TUBING CONNECTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7133754 ↗
• MalfunctionDec 19, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC WAS LEAKING AT THE RED HUB CONNECTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7131003 ↗
• MalfunctionDec 19, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC WAS LEAKING AT THE HUB CONNECTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7130923 ↗
• MalfunctionNov 15, 2017Leak/Splash

  FACILITY REPORTED TO THE SALES REP THAT THE PICC WAS PLACED ON (B)(6) 2017. RED PORT LEAKING AT THE EXTENSION HUB CONNECTION. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7034731 ↗
• MalfunctionNov 14, 2017Fluid/Blood Leak

  THE FACILITY REPORTED TO THE SALES REPRESENTATIVE THAT THERE WAS A LEAK IN THE CATHETER AT THE RED HUB/EXTENSION LEG. NO OTHER INFORMATION WAS PROVIDED. THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7031661 ↗
• MalfunctionNov 8, 2017Kinked

  DURING THE INVESTIGATION OF THE SAMPLE, IT WAS NOTED THAT THAT THE PICC CATHETER WAS KINKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7010299 ↗
• MalfunctionNov 3, 2017Leak/Splash

  IT WAS REPORTED TO THE SALES REP FROM THE FACILITY THAT THE PROVENA PICC LEAKED JUST BELOW THE HUB ON THE PURPLE TUBING OF THE EXTENSION LEG. THE PICC WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7001458 ↗
• InjuryOct 19, 2017Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT THE FACILITY WAS PLACING A PICC, RIGHT SIDED PLACEMENT AND UPON INITIAL INSERTION MET RESISTANCE. THE PLACEMENT WAS PULLED BACK; MANIPULATED THE CATHETER AND THE PICC WENT IN FINE ON THE SECOND ATTEMPT. WHEN THE PLACER WENT TO RETRACT THE SHERLOCK STYLET, SHE FELT RESISTANCE WITH THE STYLET AND REMOVED THE STYLET FROM THE PICC. UPON REMOVAL, THE STYLET WAS MISSING THE TIP. THE CATHETER WAS THEN REMOVED AND FLUSHED TO ENSURE THE TIP WAS NOT IN THE CATHETER. CHEST X-RAY SHOWED APPROXIMATELY 3.5 CM OF THE SHERLOCK TIP IN THE PATIENT'S RIGHT AXILLARY VEIN. THE PATIENT HAS LEFT SIDE SWAN-GANZ CATHETER AND PACEMAKER. THE PICC WAS TRIMMED TO 40 CM. INTERVENTIONAL RADIOLOGY RETRIEVED THE WIRE.

  Patient problems: No Code Available

  MAUDE report 6963639 ↗
• MalfunctionOct 12, 2017Break; Kinked

  REPORTED BY FACILITY THAT THIS PICC WAS PLACED (B)(6) 2017, REMOVED (B)(6) 2017 BECAUSE OF KINKS IN CATHETER AND A BREAK AT THE HUB OF THE PURPLE LUMEN HUB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6945853 ↗
• MalfunctionSep 21, 2017Break; Detachment Of Device Component

  PER SALES REP, THE FACILITY REPORTED THAT THE RED HUB ON THE CATHETER BROKE OFF. THE PICC WAS REMOVED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 6883786 ↗