ARROW IPN036043Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 10801902122756), received between Jul 3, 2023 and Jan 28, 2026 — classified as 1 injury, 87 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (30 reports).

24 other recalls cover devices cleared under the same FDA submission (K862056); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Crack

  IT WAS REPORTED "(B)(6) 2026, SKU ES-04301, FLUID LEAKAGE FROM THE NEEDLE HUB OCCURRED ON BOTH OF THE TWO CONSECUTIVE SETS DURING USAGE ON THE SAME PATIENT. THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2026-00035 AND 3006425876-2026-00051.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199054 ↗
• MalfunctionJan 28, 2026Leak/Splash

  IT WAS REPORTED THAT "(B)(6) 2026, FLUID LEAKAGE FROM THE NEEDLE HUB OCCURRED ON BOTH OF THE TWO CONSECUTIVE SETS DURING USAGE ON THE SAME PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2026-00035 AND 3006425876-2026-00051.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198991 ↗
• MalfunctionJan 21, 2026Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT "(B)(6) 2025, THE DOCTOR FROM THE INTENSIVE CARE UNIT (ICU) REPORTED THAT THE GUIDEWIRE BECAME KINKED AND THE RESISTANCE WAS FOUND DURING CATHETERIZATION. THEY CHANGED TO A NEW ONE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133416 ↗
• MalfunctionJan 21, 2026Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT "ON (B)(6) 2025, THE DOCTOR FROM THE INTENSIVE CARE UNIT (ICU) REPORTED THAT THE GUIDEWIRE BECAME KINKED AND THE RESISTANCE WAS FOUND DURING CATHETERIZATION. THEY CHANGED TO A NEW ONE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133396 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT "(B)(6) 2025, DURING THE CENTRAL VENOUS CATHETERIZATION OF A TUMOR PATIENT IN THE OPERATING ROOM, IT WAS DISCOVE RED THAT THE ARS WAS LEAKING AIR WHEN THE SYRINGE WAS WITHDRAWN." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986107 ↗
• MalfunctionDec 22, 2025Crack; Crack

  IT WAS REPORTED THAT" (B)(6) 2025, THE PATIENT UNDERWENT ULTRASOUND-GUIDED RIGHT THORACENTESIS AND DRAINAGE. AFTER THE PUNCTURE WAS IN PLACE, GAS WAS ASPIRATED. UPON WITHDRAWING THE INTRODUCER NEEDLE, A CRACK WAS OBSERVED ON THE NEEDLE HUB. THE CHANGED A NEW ONE." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864509 ↗
• MalfunctionNov 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "(B)(6) 2024, THE DOCTOR FOUND NEEDLE HUB LEAK DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597155 ↗
• MalfunctionNov 18, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "PATIENT INDICATED FOR CENTRAL VENOUS CATHETER PLACEMENT, ULTRASOUND-GUIDED PROCEDURE, SINGLE PUNCTURE, VENOUS RETURN OBTAINED, EASILY DEFORMABLE GUIDE ADVANCED, BENT ONLY UPON CONTACT WITH THE PATIENT, GUIDE MUST BE CHANGED, NEW CATHETER OPENED, GUIDE ADVANCED AND PRIOR TO MILLIMETER CUT TO ADVANCE DILATOR, THE DILATOR BENDS AT THE TIP DESPITE PROPER TECHNIQUE, A SECOND DILATOR MUST BE USED, SUBSEQUENTLY ADVANCING THE CENTRAL VENOUS CATHETER AFTER 2 UNNECESSARY PUNCTURES IN THE PROCEDURE. DILATOR BENDS AT THE TIP DESPITE PROPER TECHNIQUE, A SECOND DILATOR MUST BE USED, SUBSEQUENTLY ADVANCING THE CENTRAL VENOUS CATHETER AFTER TWO UNNECESSARY PUNCTURES IN AN ULTRASOUND-GUIDED PROCEDURE, PUNCTURES REQUIRED DUE TO FAILURES IN THE ARROW BRAND CENTRAL VENOUS CATHETER." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE" ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00935 AND .

  Patient problems: Needle Stick/Puncture

  MAUDE report 23582193 ↗
• MalfunctionNov 18, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "PATIENT INDICATED FOR CENTRAL VENOUS CATHETER PLACEMENT, ULTRASOUND-GUIDED PROCEDURE, SINGLE PUNCTURE, VENOUS RETURN OBTAINED, EASILY DEFORMABLE GUIDE ADVANCED, BENT ONLY UPON CONTACT WITH THE PATIENT, GUIDE MUST BE CHANGED, NEW CATHETER OPENED, GUIDE ADVANCED AND PRIOR TO MILLIMETER CUT TO ADVANCE DILATOR, THE DILATOR BENDS AT THE TIP DESPITE PROPER TECHNIQUE, A SECOND DILATOR MUST BE USED, SUBSEQUENTLY ADVANCING THE CENTRAL VENOUS CATHETER AFTER 2 UNNECESSARY PUNCTURES IN THE PROCEDURE. DILATOR BENDS AT THE TIP DESPITE PROPER TECHNIQUE, A SECOND DILATOR MUST BE USED, SUBSEQUENTLY ADVANCING THE CENTRAL VENOUS CATHETER AFTER TWO UNNECESSARY PUNCTURES IN AN ULTRASOUND-GUIDED PROCEDURE, PUNCTURES REQUIRED DUE TO FAILURES IN THE ARROW BRAND CENTRAL VENOUS CATHETER." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00935 AND 9680794-2025-00992.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582157 ↗
• MalfunctionNov 18, 2025Migration; Migration

  IT WAS REPORTED THAT "PATIENT WHO HAD UNDERGONE CVC ADVANCEMENT IN THE ICU WITHOUT COMPLICATIONS. UPON REVIEWING THE POST-CATHETER X-RAY, CVC WAS EVIDENT IN THE LEFT SUBCLAVIAN VEIN IN THE DIRECTION OF THE RIGHT SUBCLAVIAN VEIN, BUT WAS NOT FOUND IN THE ATRIOCAVAL JUNCTION. THEREFORE, CENTRAL VENOUS CATHETER PLACEMENT WAS INDICATED, A PROCEDURE GUIDED BY ULTRASOUND WITH A SINGLE PUNCTURE. VENOUS RETURN WAS ACHIEVED. HOWEVER, WHEN ADVANCING THE GUIDEWIRE, WHICH WAS EASILY DEFORMED, A MILLIMETER CUT WAS MADE TO DILATE. THE CENTRAL VENOUS CATHETER DILATOR WAS ADVANCED, BUT THE TIP WAS DAMAGED. AN ATTEMPT HAD PREVIOUSLY BEEN MADE TO ADVANCE THE ARROW CENTRAL VENOUS CATHETER, WITH MULTIPLE FAILURES OF THE DEVICE (THE ONLY ONE AVAILABLE AT THE TIME OF REQUESTING THE DEVICE FROM THE PHARMACY). IT WAS NECESSARY TO CHANGE THE DEVICE, INCLUDING THE PREVIOUS OCCASION OF FAILURE, FOR A TOTAL OF THREE CENTRAL VENOUS CATHETERS TO ADVANCE THE GUIDE WITHOUT DEFORMATION AND ALSO TO DILATE WITHOUT BENDING THE VENOUS CATHETER. PATIENT WITH DIFFICULT VENOUS ACCESS, IN WHOM AN ATTEMPT HAD BEEN MADE TO ADVANCE A PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER USING ULTRASOUND. IN ADDITION, WHEN THE GUIDEW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582063 ↗
• MalfunctionNov 18, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "PATIENT WHO HAD UNDERGONE CVC ADVANCEMENT IN THE ICU WITHOUT COMPLICATIONS. UPON REVIEWING THE POST-CATHETER X-RAY, CVC WAS EVIDENT IN THE LEFT SUBCLAVIAN VEIN IN THE DIRECTION OF THE RIGHT SUBCLAVIAN VEIN BUT WAS NOT FOUND IN THE ATRIOCAVAL JUNCTION. THEREFORE, CENTRAL VENOUS CATHETER PLACEMENT WAS INDICATED, A PROCEDURE GUIDED BY ULTRASOUND WITH A SINGLE PUNCTURE. VENOUS RETURN WAS ACHIEVED. HOWEVER, WHEN ADVANCING THE GUIDEWIRE, WHICH WAS EASILY DEFORMED, A MILLIMETER CUT WAS MADE TO DILATE. THE CENTRAL VENOUS CATHETER DILATOR WAS ADVANCED, BUT THE TIP WAS DAMAGED. AN ATTEMPT HAD PREVIOUSLY BEEN MADE TO ADVANCE THE ARROW CENTRAL VENOUS CATHETER, WITH MULTIPLE FAILURES OF THE DEVICE (THE ONLY ONE AVAILABLE AT THE TIME OF REQUESTING THE DEVICE FROM THE PHARMACY). IT WAS NECESSARY TO CHANGE THE DEVICE, INCLUDING THE PREVIOUS OCCASION OF FAILURE, FOR A TOTAL OF THREE CENTRAL VENOUS CATHETERS TO ADVANCE THE GUIDE WITHOUT DEFORMATION AND ALSO TO DILATE WITHOUT BENDING THE VENOUS CATHETER. PATIENT WITH DIFFICULT VENOUS ACCESS, IN WHOM AN ATTEMPT HAD BEEN MADE TO ADVANCE A PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER USING ULTRASOUND. IN ADDITION, WHEN THE GUIDEWI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582035 ↗
• MalfunctionNov 18, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "PATIENT WHO HAD UNDERGONE CVC ADVANCEMENT IN THE ICU WITHOUT COMPLICATIONS. UPON REVIEWING THE POST-CATHETER X-RAY, CVC WAS EVIDENT IN THE LEFT SUBCLAVIAN VEIN IN THE DIRECTION OF THE RIGHT SUBCLAVIAN VEIN, BUT WAS NOT FOUND IN THE ATRIOCAVAL JUNCTION. THEREFORE, CENTRAL VENOUS CATHETER PLACEMENT WAS INDICATED, A PROCEDURE GUIDED BY ULTRASOUND WITH A SINGLE PUNCTURE. VENOUS RETURN WAS ACHIEVED. HOWEVER, WHEN ADVANCING THE GUIDEWIRE, WHICH WAS EASILY DEFORMED, A MILLIMETER CUT WAS MADE TO DILATE. THE CENTRAL VENOUS CATHETER DILATOR WAS ADVANCED, BUT THE TIP WAS DAMAGED. AN ATTEMPT HAD PREVIOUSLY BEEN MADE TO ADVANCE THE ARROW CENTRAL VENOUS CATHETER, WITH MULTIPLE FAILURES OF THE DEVICE (THE ONLY ONE AVAILABLE AT THE TIME OF REQUESTING THE DEVICE FROM THE PHARMACY). IT WAS NECESSARY TO CHANGE THE DEVICE, INCLUDING THE PREVIOUS OCCASION OF FAILURE, FOR A TOTAL OF THREE CENTRAL VENOUS CATHETERS TO ADVANCE THE GUIDE WITHOUT DEFORMATION AND ALSO TO DILATE WITHOUT BENDING THE VENOUS CATHETER. PATIENT WITH DIFFICULT VENOUS ACCESS, IN WHOM AN ATTEMPT HAD BEEN MADE TO ADVANCE A PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER USING ULTRASOUND. IN ADDITION, WHEN THE GUIDEW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581987 ↗
• MalfunctionOct 15, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT" ON (B)(6) 2025, DURING THE OPERATION, THE SWG CAN'T INSERTED INTO ARS, AFTER ADJUST THE SWG CAN'T INSERTED INTO." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278363 ↗
• MalfunctionApr 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "(B)(6) 2025, PATIENT IN CRITICAL CONDITION WITH INFECTIOUS SHOCK, DURING THE INSERTION, THE DOCTOR FOUND THE ARS LEAK DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925070 ↗
• MalfunctionJan 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE ARS LEAK DURING USED ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282542 ↗
• MalfunctionJan 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE EXTENSION LINE LEAK DURING USED ON THE PATIENT. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217782 ↗
• MalfunctionJan 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE SWG KINKED WHEN THE SWG INSERTED INTO ARS DURING USED ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196624 ↗
• MalfunctionJan 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE SWG/ARS RESISTANCE DURING USED ON THE PATIENT WHEN THE SWG INSERTED INTO THE ARS. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149466 ↗
• MalfunctionJan 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE ARS LEAK DURING USE ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079758 ↗
• MalfunctionDec 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE EXTENSION LINE WAS FOUND LEAK DURING USED ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. THE PATIENT CONDITION IS FINE AND HAD NO HARM OR INJURY. A MEDICAL INTERVENTION WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20962053 ↗
• MalfunctionDec 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "ON (B)(6) 2024, DURING WARD ROUNDS, THE PATIENT WAS FOUND TO BE CALMLY RESTING IN BED AND CONSCIOUS, AND WAS FOUND TO HAVE EXTRAVASATION OF DRAINAGE FLUID IN THE DRAINAGE TUBE, AND THE CAUSE WAS FOUND JUNCTURE HUB LEAKED, WHICH WAS IMMEDIATELY REPORTED TO THE DOCTOR ON DUTY, WHO STOPPED USING THE DRAINAGE TUBE IN COMPLIANCE WITH THE INSTRUCTIONS AFTER CHECKING IT." THE OPERATOR CHANGED TO A NEW SET. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834920 ↗
• MalfunctionNov 27, 2024Crack; Crack

  IT WAS REPORTED "ON (B)(6) 2024, IN THE SECOND DAY AFTER INSERTION, THE NURSE FOUND THE EXTENSION LINE CRACK. THE NURSE DESCRIBED THE PATIENT AS NOT PULLING AT ALL." THE OPERATOR CHANGED TO A NEW SET. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797640 ↗
• MalfunctionNov 25, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED "ON (B)(6) 2024, PATIENT NEEDS TO ESTABLISH CENTRAL VENOUS ACCESS FOR LUNG NODULE SURGERY, USING CENTRAL VENOUS CATHETER KIT, AFTER SUCCESSFUL PUNCTURE VIA INTERNAL JUGULAR VEIN, THE SWG COULD NOT BE WITHDRAWN FROM ARS, RESULTING IN RE-PUNCTURING AND INCREASING PATIENT'S SUFFERING." THE OPERATOR CHANGED TO A NEW SET. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Needle Stick/Puncture

  MAUDE report 20771072 ↗
• MalfunctionNov 8, 2024Difficult to Remove; Difficult to Advance; Material Twisted/Bent; Difficult to Remove; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED " ON (B)(6) 2024, THE DOCTOR FOUND THE SWG WAS DIFFICULT TO ADVANCE AND WITHDRAW FROM THE ARS. THEY CHANGED TO A NEW ONE, IT HAS THE SAME ISSUE. THEY CHANGED TO THE THIRD ONE, IT WAS SUCESSFUL. THE OPERATION TIME WAS DELAYED." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER INCLUDES:3006425876-2024-01086.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646443 ↗
• MalfunctionNov 8, 2024Difficult to Remove; Difficult to Advance; Material Twisted/Bent; Difficult to Remove; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED "ON 14 OCT 2024, THE DOCTOR FOUND THE SWG WAS DIFFICULT TO ADVANCE AND WITHDRAW FROM THE ARS. THEY CHANGED TO A NEW ONE, IT HAS THE SAME ISSUE. THEY CHANGED TO THE THIRD ONE, IT WAS SUCESSFUL. THE OPERATION TIME WAS DELAYED." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER INCLUDES: 3006425876-2024-01102.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646419 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K862056. One submission often covers many models, so check the product and lot details in each record.

• Z-2377-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSE
• Z-1118-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
• Z-1119-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396
• Z-0723-2019 · Nov 14, 2018 · Terminated
  Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide sho
• Z-2818-2018 · Jul 10, 2018 · Terminated
  HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous cathe
• Z-2819-2018 · Jul 10, 2018 · Terminated
  HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous cath
• Z-2336-2018 · May 11, 2018 · Terminated
  Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single
• Z-1967-2018 · Apr 11, 2018 · Terminated
  Maximal Barrier Drape; Product Code: ASK-04000-HMC
• Z-1982-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2
• Z-1978-2018 · Apr 11, 2018 · Terminated
  Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
• Z-1332-2018 · Dec 22, 2017 · Terminated
  (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12
• Z-0654-2018 · Oct 17, 2017 · Terminated
  Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
• Z-0652-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dat
• Z-0648-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018
• Z-0650-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018

…and 9 more.