PowerPICC SOLO2 HF Catheter with Sherlock Tip Location System (TLS) Stylet 9395118QRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741035913), received between Feb 22, 2017 and Apr 30, 2021 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (5 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.

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.

• MalfunctionApr 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN FLUSHING PICC, 2 OUT OF 3 LUMENS LEAKING AND HOLE NOTED NEAR THE HUB. PICC REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757248 ↗
• MalfunctionMar 24, 2020Material Deformation; Material Deformation

  IT WAS REPORTED PICC KINKED IN UPPER ARM CAUSING OCCLUSION AND REQUIRED REPLACEMENT. NO OTHER INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9876122 ↗
• InjuryMar 3, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PICC WAS INSERTED ON (B)(6) 2019, X-RAYS DONE AT THAT TIME. CT WAS DONE SAME DAY WHICH SUGGESTED A FOREIGN BODY. ON REEXAMINATION, A POSSIBLE PICC GUIDEWIRE WAS FOUND ON THE X-RAY. PICC DEPARTMENT WAS NOTIFIED OF THE POTENTIAL ISSUE ON (B)(6) 2019. USERS EXAMINED THEIR CURRENT PICCS AND DETERMINED THE ISSUE WITH A SPECIFIC LOT OF PICC. APPARENTLY ABLE TO REPRODUCE THE TIP BREAKING OFF ON THIS LOT WITH EASE. PATIENT UNDERWENT INTERVENTIONAL RADIOLOGY TO HAVE THE FOREIGN BODY REMOVED WHICH WAS CONFIRMED TO BE A TIP OF PICC GUIDEWIRE. ON 1/10/2020 - ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT "CANNULATION WAS EASY. INSERTION WENT WELL TILL BRACHIOCEPHALIC AREA WHERE PICC WENT JUGULAR SEVERAL TIMES. VARIOUS METHODS OF GENTLY PULLING PICC BACK WITH STYLET IN AND STYLET OUT A FEW CM¿S TO CREATE A ¿FLOPPY¿ TIP. NORMAL PICC INSERTION TECHNIQUES USING SHERLOCK AS A GUIDE. THE PICC WITH STYLET INSIDE WAS REMOVED COMPLETELY AFTER 5TH ATTEMPTED TO PROPERLY POSITION PICC OUT OF THE JUGULAR. NOTICED PICC WAS CURVED. STYLET REMOVED OUT OF PICC AND NOTICED STYLET WAS SPIRAL. PICC KEPT BUT SPIRALED STYLET DISCARDED AND NEW PICC KIT OPENED TO USE NEW STYLET FROM THAT

  Patient problems: Foreign Body In Patient

  MAUDE report 9779818 ↗
• MalfunctionFeb 28, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT AT THE FACILITY WHILE INSPECTING THE GUIDEWIRE, THE TIP BROKE OFF EASILY. THE DEVICE WAS NOT USED ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9770264 ↗
• MalfunctionFeb 28, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT AT THE FACILITY WHILE INSPECTING THE GUIDEWIRE, THE TIP BROKE OFF EASILY. THE DEVICE WAS NOT USED ON A PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9770154 ↗
• MalfunctionFeb 27, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT GUIDEWIRE BROKE OFF IN A PATIENT WHILE INSERTING A PICC. INSERTION SITE: VENOUS LEFT TECHNIQUE: PICC CM+ INTRNAL LENGTH: 42CM LEFT CEPHALIC VEIN UNABLE TO THREAD PAST 30 CM. GUIDEWIRE BROKE MID PROCEDURE. ALL PIECES RECOVERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765480 ↗
• InjuryJan 30, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PICC WAS INSERTED ON (B)(6)2019, X-RAYS DONE AT THAT TIME. CT WAS DONE SAME DAY WHICH SUGGESTED A FOREIGN BODY. ON REEXAMINATION, A POSSIBLE PICC GUIDEWIRE WAS FOUND ON THE X-RAY. PICC DEPARTMENT WAS NOTIFIED OF THE POTENTIAL ISSUE ON 30DEC2019. USERS EXAMINED THEIR CURRENT PICCS AND DETERMINED THE ISSUE WITH A SPECIFIC LOT OF PICC. APPARENTLY ABLE TO REPRODUCE THE TIP BREAKING OFF ON THIS LOT WITH EASE. PATIENT UNDERWENT INTERVENTIONAL RADIOLOGY TO HAVE THE FOREIGN BODY REMOVED WHICH WAS CONFIRMED TO BE A TIP OF PICC GUIDEWIRE. 1/10/2020 - ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT "CANNULATION WAS EASY. INSERTION WENT WELL TILL BRACHIOCEPHALIC AREA WHERE PICC WENT JUGULAR SEVERAL TIMES. VARIOUS METHODS OF GENTLY PULLING PICC BACK WITH STYLET IN AND STYLET OUT A FEW CM¿S TO CREATE A ¿FLOPPY¿ TIP. NORMAL PICC INSERTION TECHNIQUES USING SHERLOCK AS A GUIDE. THE PICC WITH STYLET INSIDE WAS REMOVED COMPLETELY AFTER 5TH ATTEMPTED TO PROPERLY POSITION PICC OUT OF THE JUGULAR. NOTICED PICC WAS CURVED. STYLET REMOVED OUT OF PICC AND NOTICED STYLET WAS SPIRAL. PICC KEPT BUT SPIRALED STYLET DISCARDED AND NEW PICC KIT OPENED TO USE NEW STYLET FROM THAT KIT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9650091 ↗
• MalfunctionMar 2, 2018Kinked

  IT WAS REPORTED BY THE FACILITY THAT THEY WERE UNABLE TO FLUSH THE PICC. PICC WAS PLACED AT ANOTHER FACILITY. X-RAY CONFIRMED THE PICC IS KINKED IN THE ARM JUST ABOVE THE INSERTION SITE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7311479 ↗
• MalfunctionJul 19, 2017Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT AFTER INSERTION IT WAS NOTICED THAT THERE WAS A FRACTURE AT THE END OF THE WHITE LUMEN. THE LUMEN WAS STATED TO BE UNUSABLE AS FLUID WAS LEAKING FROM FRACTURE. THE PATIENT WAS CRITICALLY ILL WITH LIMITED IV ACCESS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6726301 ↗
• MalfunctionFeb 22, 2017Kinked

  FACILITY REPORTED THAT A PICC KINKED AT THE HUB RIGHT AFTER INSERTION. NO PATIENT INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6351382 ↗
• MalfunctionFeb 22, 2017Kinked

  FACILITY REPORTED THAT THE CATHETER KINKED AFTER IT WAS INSERTED INTO THE HUB. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6350831 ↗