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PowerPICC SOLO2 HF Catheter with Sherlock Tip Location System (TLS) Stylet 9395108QRecalls & reported problems

Bard Access Systems, Inc. · PowerPICC SOLO HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741035890), received between Jun 24, 2020 and Jun 24, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Frayed” (1 report).

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

Device problems

  • Material Frayed1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 24, 2020Material Frayed; Material Frayed

    IT WAS REPORTED "RN INSERTED THE PICC LINE WITHOUT ANY COMPLICATIONS. THIS RN FELT NO RESISTANCE UPON REMOVING THE STYLET POST INSERTION. CHEST X-RAY CONFIRMED RADIOPAQUE STYLET IN CATHETER FOR TIP CONFIRMATION. ALSO NOTED THAT ABOUT 5-6CM OF STYLET NO LONGER IN PICC LINE. THE STYLET BROKE AND WAS LODGED IN PULMONARY ARTERY.¿ ADDITIONAL INFORMATION RCVD 06/04/2020 : THE PATIENT WAS PREPPED AND DRAPPED IN THE USUAL STERILE FASHION AFTER SURGICAL TIMEOUT WAS PERFORMED. PERCUTANEOUS ACCESS WAS GAINED TO THE LEFT BASILICA VEIN WITH 21G INTRODUCER NEEDLE UNDER ULTRASOUND GUIDANCE. USING A MODIFIED SELDINGER TECHNIQUE A 0.46MM X 50CM GUIDEWIRE WAS THEN INSERTED THROUGH THE INTRODUCER NEEDLE ALLOWING THE NEEDLE TO BE REMOVED. A MICROINTRODUCER WAS INSERTED OVER THE GUIDEWIRE ALLOWING THE GUIDEWIRE TO BE REMOVED. AFTER REMOVING THE VESSEL DILATOR, THE PICC WAS THEN INSERTED THROUGH THE MICROINTRODUCER INTO THE SELECTED VEIN. THE PEEL-AWAY SHEATH WAS THEN REMOVED. CR REVEALS TIP IN LOWER SVC PENDING RADIOLOGIST REVIEW. ALL PORTS FLUSHED AND ASPIRATED EASILY. THE PICC WAS SECURED USING THE STATLOCK DEVICE AND STERILE DRESSINGS WERE APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS RE

    Patient problems: Foreign Body In Patient

    MAUDE report 10192743 ↗

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Sources and updates

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