Bard Poly MidlineRecalls & reported problems across all models

We found 9 models of Bard Poly Midline by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 14 adverse event reports in the FDA's MAUDE database, received between Aug 18, 2016 and Mar 17, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Bard Poly Midline recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-2656-2026 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

Most reported Bard Poly Midline problems

Bard Poly Midline models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bard Poly Midline CK000495A

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall3 reports
• Bard Poly Midline CK000566

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall1 report
• BARD Poly Midline 4154108D

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  2 reports
• BARD Poly Midline CK000400

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  2 reports
• Bard Poly Midline CK000107A

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  2 reports
• BARD Poly Midline 4154108

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 report
• BARD Poly Midline CK000523

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 report
• Bard Poly Midline CK000716

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 report
• Bard Poly Midline CK000107B

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 report

Recent Bard Poly Midline adverse event reports

The 14 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Material Frayed; Material Frayed

  IT WAS REPORTED BUT THE CUSTOMER THAT THE GUIDE WIRES CAME UNRAVELED. CUSTOMER OPENED A SECOND KIT. THERE WAS NO ISSUE WITH THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618533 ↗
• MalfunctionApr 22, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED "INTRODUCER DIDN'T BREAK COMPLETELY AND HAD TO DO GUIDEWIRE EXCHANGE. POSSIBLE LOSS OF VESSEL AND PATIENT WITH VERY LIMITED VENOUS ACCESS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14188456 ↗
• MalfunctionDec 16, 2021Material Deformation; Material Deformation

  IT WAS REPORTED A FAULTY DILATOR. ADD INFO RCVD: PLACED LINE WITH FAULTY DILATOR. USED DILATOR FROM A SEPARATE KIT TO COMPLETE LINE PLACEMENT. WAS THERE PATIENT HARM REPORTED?: NO. (B)(6) 2021: THE RETURNED SAMPLE EXHIBITED A DEFORMED SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018400 ↗
• MalfunctionJul 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THE WIRES BEING FLIMSY AND DULL CAUSING PROBLEMS WITH INSERTIONS. THE WIRES ARE NOT THREADING PROPERLY, KINKING AND LOOPING ON THEMSELVES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135017 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA MS&S "CALLER STATES A FEW WEEKS AGO HE HAD HIS MIDLINE TAKEN OUT. HE STATES HE NOW FEELS PAIN AND TENDERNESS A FEW INCHES FROM WHERE THE PORT WAS INSERTED. CALLER ASKING IF HE SHOULD CONTACT HIS DOCTOR ABOUT THIS. ALSO WHAT COULD BE CAUSING THIS ISSUE." MS&S RESPONSE "EXPLAINED THAT HE SHOULD CONTACT HIS PHYSICIAN ABOUT THIS PAIN IN HIS ARM. EXPLAINED THAT SOME MEDICATIONS CAN IRRITATE THE VESSELS OF THE UPPER ARM WHEN THEY ARE GIVEN VIA A MIDLINE. EXPLAINED THAT THIS IRRITATION CAN CAUSE RESIDUAL INFLAMMATION IN THE VEIN. IT COULD ALSO BE SOMETHING MORE SERIOUS LIKE AN INFECTION OR BLOOD CLOT. THE ONLY WAY TO KNOW FOR SURE IS TO HAVE IT EVALUATED FURTHER BY HIS PHYSICIAN." ADDITIONAL INFORMATION RECEIVED 03/22/2021: CONCOMITANT THERAPY: "SAW DR. ON (B)(6), VEIN HARD AND SORE, DIAGNOSED A BLOOD CLOT, PRESCRIBED 15 MINUTE HEAT THERAPY THREE TIMES A DAY, CONTACT HIM IF WORSE, REPORT CONDITION IN 5 DAYS."

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 11655460 ↗
• MalfunctionJan 27, 2021Material Split, Cut or Torn

  IT WAS REPORTED "THE GLOVES IN THE KIT KEEP RIPPING" ADDITIONAL INFO. RECEIVED 01/04/2021: "THERE WAS NO HARM TO PATIENT, NEW GLOVES WERE OBTAINED AND PROCEDURE COMPLETED. THE GLOVES RIPPED AND WERE THROWN AWAY. THE OCCURRENCE HAPPENED MOST OF DECEMBER WITH REEW2786 LOT NUMBERS ON MIDLINE KITS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11236630 ↗
• MalfunctionAug 26, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THE MICROINTRODUCER FOLDED (FISH MOUTHED) WHEN TRYING TO INSERT IT. IT WAS STATED THE USER HAD TO TRIM THE MICROINTRODUCER AND REINSERT NON-TAPERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10457518 ↗
• MalfunctionJul 15, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED ONE OF THE KITS WE USED ON A PATIENT HAD THE INTRODUCER DAMAGED OR SPLIT IN HALF. PATIENT WAS NOT INJURED DURING THE PROCEDURE. WE HAD TO OPEN ANOTHER KIT TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10279986 ↗
• MalfunctionJan 9, 2020Material Discolored; Expiration Date Error; Material Discolored; Expiration Date Error

  IT WAS REPORTED THAT KIT CONTAINED EXPIRED AND DISCOLORED ULTRASOUND GEL. 12/20/2019-BASED ON PRELIMINARY EVALUATION, KIT WAS LIKELY SHIPPED WITH EXPIRED US GEL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9572115 ↗
• MalfunctionAug 1, 2017Detachment Of Device Component

  PER SALES REP, THE FACILITY REPORTED THAT THE CATHETER CAME APART BELOW THE HUB WHILE INSERTED IN THE PATIENT. THE CATHETER WAS REMOVED WITH NO REPORT OF HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6758900 ↗
• MalfunctionJul 5, 2017Knotted

  PER SALES REP, THE RN REPORTED AN "INCIDENT OF KNOT IN GUIDEWIRE".

  Patient problems: No Information

  MAUDE report 6685831 ↗
• MalfunctionMay 10, 2017Unraveled Material

  IT WAS REPORTED BY RN THAT DURING THE PROCEDURE THE GUIDEWIRE TIP "UNSPOOLED". ON 04/25/2017- ADDITIONAL INFORMATION RECEIVED FROM RN STATED, "PATIENT RETRACTED ARM WHILE THREADING GUIDE WIRE THROUGH INSERTION NEEDLE (POSSIBLE SHEAR OCCURRED) AND NITINOL WIRE TIP UNSPOOLED WHILE RETRACTING WIRE. A WIRE FRAGMENT IN TISSUE ON X-RAY OF HUMERUS. PATIENT SENT TO I.R. FOR RETRIEVAL OF WIRE FRAGMENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 6556728 ↗
• MalfunctionApr 19, 2017Leak/Splash

  IT WAS REPORTED BY THE FACILITY THAT THE CATHETER LEAKED DURING INSERTION WHILE FLUSHING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6504548 ↗
• MalfunctionAug 18, 2016Fluid/Blood Leak

  ON 7/26/2016- PER SALES REPRESENTATIVE, USER FACILITY REPORTED THAT A MIDLINE CATHETER LEAKED AFTER TWO DAYS AND WAS REMOVED AND REPLACED. ON 08/08/2016 - FACILITY CONTACT REPORTED THAT THE MIDLINE LEAK WAS LOCATED "OUTSIDE/INSIDE THE LUMEN". CONTACT STATED THAT HE DID NOT NICK THE SKIN BUT NOTICED AFTER A FEW DAYS THAT THE BIO PATCH BECAME WET AFTER THE PATIENT RECEIVED IV ANTIBIOTICS. HE STATED THAT WHEN THE CATHETER WAS FLUSHED, THERE WAS A LEAK COMING FROM THE EXIT SITE. HE REPORTED THAT WHEN HE WAS CHANGING THE DRESSING AND FLUSHED THE LINE, "A SUDDEN GUSH OF BLOOD CAME OUT FROM THE EXIT SITE". HE REPORTED HE INSERTED THIS LINE. THE CATHETER WAS DISCONTINUED AND HE NOTICED THE CATHETER WAS "CROOKED, NOT STRAIGHT." ON 08/08/2016 - FACILITY CONTACT REPORTED THAT THE CATHETER WAS PLACED IN THE UPPER ARM AND NEVER IN THE AC. THEY USE THE BASILICA OR CEPHALIC VEIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5886834 ↗

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