PowerPICC SOLO2 Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet 1295108Recalls & reported problems
Bard Access Systems, Inc. · PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Nurse Full Tray with Microintroducer · 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 00801741034596), received between Jul 5, 2016 and Jul 5, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device1
- Uncoiled1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 5, 2016Entrapment of Device; Uncoiled
ON (B)(6) 2016- PER SALES REPRESENTATIVE, USER FACILITY REPORTED THAT UPON INSERTION OF THE PICC LINE THE GUIDEWIRE GOT CAUGHT IN THE TISSUE AND CAME UNCOILED. IT WAS STATED THAT THE TIP OF THE GUIDEWIRE WAS LODGED IN THE SUBCUTANEOUS TISSUE AND WAS REMOVED IN INTERVENTIONAL RADIOLOGY. THERE WAS NO PATIENT HARM. THE RN STATED THAT SHE DID NOT THINK IT WAS A QUALITY ISSUE BUT A DIFFICULT TISSUE AND ANATOMY ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5769067 ↗
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- PowerPICC SOLO2 Catheter 1194108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls216 reports
- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
- PowerPICC Catheter 3275118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days272 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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