PowerPICC SOLO Provena CK000868BRecalls & reported problems
Bard Access Systems, Inc. · Catheter Placement Kit · 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 00801741231704), received between Dec 18, 2025 and Dec 18, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Material Frayed1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2025Material Frayed; Material Frayed
IT WAS REPORTED, CLINICIAN WAS PLACING A PICC AS NORMAL. HE WAS IN THE VEIN AND INSERTED WIRE AND MET RESISTANCE IN THE SHOULDER AND STARTED TO RETRACT THE WIRE BACK. HE MET RESISTANCE LIKE THE WIRE SNAGGED. PULLED THE NEEDLE OUT AND STARTED TO PULL THE WIRE AND STILL MET RESISTANCE. THE OUTSIDE COIL OF THE WIRE, OUTER WINDING OF THE WIRE CAME OUT, BUT REALIZED THAT THERE WAS STILL WIRE IN THE PATIENT. HE LEFT THE TORNIQUET ON AN APPLIED PRESSURE WHERE THE WIRE WAS. FELT LIKE THE WIRE SNAGGED ON THE BEVEL. THE PATIENT WAS RESTLESS AND MOVING. THE VEIN HALF A CENTIMETER DEEP. 42% CVR. 4FRDL. PATIENT GOT CHEST X-RAY AND CONFIRMED WIRE WAS IN THE VEIN AND LOOKED THROUGH ULTRASOUND. PATIENT GOT INTO SURGERY AND THE WIRE LOGGED ITSELF INTO THE TISSUE. THE DOCTOR RETRIEVED WIRE. NURSE PULLED (B)(4) KITS OF THAT LOT # AND SET THEM ASIDE. PATIENT WAS 39 YEARS OLD WITH PNEUMONIA. WHITE COUNT OVER 50,000. HE WAS IN THE ICU. ACUTE ONSET CHF.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23838284 ↗
Other Catheter, intravascular, therapeutic, long-term greater than 30 days devices
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- L-Cath™ S/L PICC S/L 26GA (1.9F) x 30cmArgon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days2 recalls245 reports
- 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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