ARROW IPN046313 (REF JC-05400-DCS)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801902062512), received between Dec 12, 2022 and May 8, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (6 reports).

4 other recalls cover devices cleared under the same FDA submission (K103658); 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT "THE LOW RESISTANCE SYRINGE IS JUDGED TO BE OF POOR QUALITY LEADING TO THE REPETITION OF DURAL BREACHES IN PATIENTS DURING CHILDBIRTH". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 16891305 ↗
• MalfunctionApr 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "DURING THE INSERTION OF AN EPIDURAL CATHETER IN THE OPERATING ROOM, WHEN THE [OPERATOR] CONNECTED THE LOR SYRINGE, THE [OPERATOR] NOTICED THAT THE PLUNGER WAS NOT SEALED PROPERLY AND THAT IT LED TO A PHYSIOLOGICAL SERUM LEAK ALL AROUND THE PLUNGER. THE SYRINGE WAS IMPOSSIBLE TO USE. WE CHANGED THE KIT". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16776564 ↗
• MalfunctionDec 13, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT IMMEDIATELY AFTER PLACEMENT, 6 CATHETERS ON 6 DIFFERENT PATIENTS WERE NON PASSABLE (OCCLUDED) AND HAD TO BE REPLACED. THE 6 EVENTS OCCURRED IN (B)(6) 2022, THE EXACT DATE IS UNKNOWN IN EACH CASE. A PATIENT WAS NOT HARMED, EACH CATHETER WAS REPLACED IMMEDIATELY WITHOUT AN ISSUE. ASSOCIATED MDRS: 3006425876-2022-01138, 3006425876-2022-01139, 3006425876-2022-01140, 3006425876-2022-01142, 3006425876-2022-01137.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971798 ↗
• MalfunctionDec 13, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT IMMEDIATELY AFTER PLACEMENT, 6 CATHETERS ON 6 DIFFERENT PATIENTS WERE NON PASSABLE (OCCLUDED) AND HAD TO BE REPLACED. THE 6 EVENTS OCCURRED IN DECEMBER 2022, THE EXACT DATE IS UNKNOWN IN EACH CASE. A PATIENT WAS NOT HARMED, EACH CATHETER WAS REPLACED IMMEDIATELY WITHOUT AN ISSUE. ASSOCIATED MDRS: 3006425876-2022-01138, 3006425876-2022-01139, 3006425876-2022-01140, 3006425876-2022-01141, 3006425876-2022-01137.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971756 ↗
• MalfunctionDec 13, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT IMMEDIATELY AFTER PLACEMENT, 6 CATHETERS ON 6 DIFFERENT PATIENTS WERE NON PASSABLE (OCCLUDED) AND HAD TO BE REPLACED. THE 6 EVENTS OCCURRED IN DECEMBER 2022, THE EXACT DATE IS UNKNOWN IN EACH CASE. A PATIENT WAS NOT HARMED, EACH CATHETER WAS REPLACED IMMEDIATELY WITHOUT AN ISSUE. ASSOCIATED MDRS: 3006425876-2022-01138, 3006425876-2022-01139, 3006425876-2022-01141, 3006425876-2022-01142, 3006425876-2022-01137.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971659 ↗
• MalfunctionDec 13, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT IMMEDIATELY AFTER PLACEMENT, 6 CATHETERS ON 6 DIFFERENT PATIENTS WERE NON PASSABLE (OCCLUDED) AND HAD TO BE REPLACED. THE 6 EVENTS OCCURRED IN (B)(6) 2022, THE EXACT DATE IS UNKNOWN IN EACH CASE. A PATIENT WAS NOT HARMED, EACH CATHETER WAS REPLACED IMMEDIATELY WITHOUT AN ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971614 ↗
• MalfunctionDec 13, 2022Obstruction of Flow; Obstruction of Flow

  LOG. IT WAS REPORTED THAT IMMEDIATELY AFTER PLACEMENT, 6 CATHETERS ON 6 DIFFERENT PATIENTS WERE NON PASSABLE (OCCLUDED) AND HAD TO BE REPLACED. THE 6 EVENTS OCCURRED IN (B)(6) 2022, THE EXACT DATE IS UNKNOWN IN EACH CASE. A PATIENT WAS NOT HARMED, EACH CATHETER WAS REPLACED IMMEDIATELY WITHOUT AN ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971578 ↗
• MalfunctionDec 13, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT IMMEDIATELY AFTER PLACEMENT, 6 CATHETERS ON 6 DIFFERENT PATIENTS WERE NON PASSABLE (OCCLUDED) AND HAD TO BE REPLACED. THE 6 EVENTS OCCURRED IN (B)(6) 2022, THE EXACT DATE IS UNKNOWN IN EACH CASE. A PATIENT WAS NOT HARMED, EACH CATHETER WAS REPLACED IMMEDIATELY WITHOUT AN ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971487 ↗
• MalfunctionDec 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE EPIDURAL SET SYRINGE NOT GENERALLY VACUUM TO IDENTIFY EPIDURAL SPACE. PLUNGERS LOOSE AND FALLING OFF. THE DEVICE WAS REMOVED ENTIRELY AND REPLACED WITH A DIFFERENT BRAND (B BRAUN) SUCCESSFULLY. THERE WAS NO SERIOUS INJURY, COMPLICATIONS, OR DELAY CAUSED TO THE PATIENT. ONLY EXACERBATION OF HEADACHE DUE TO MULTIPLE ATTEMPTS.

  Patient problems: Headache

  MAUDE report 15958143 ↗
• MalfunctionDec 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE EPIDURAL SET SYRINGE NOT GENERALLY VACUUM TO IDENTIFY EPIDURAL SPACE. PLUNGERS LOOSE AND FALLING OFF. THE DEVICE WAS REMOVED ENTIRELY AND REPLACED WITH A DIFFERENT BRAND (B BRAUN) SUCCESSFULLY. THERE WAS NO SERIOUS INJURY, COMPLICATIONS, OR DELAY CAUSED TO THE PATIENT. ONLY EXACERBATION OF HEADACHE DUE TO MULTIPLE ATTEMPTS.

  Patient problems: Headache

  MAUDE report 15958120 ↗
• MalfunctionDec 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE EPIDURAL SET SYRINGE NOT GENERALLY VACUUM TO IDENTIFY EPIDURAL SPACE. PLUNGERS LOOSE AND FALLING OFF. THE DEVICE WAS REMOVED ENTIRELY AND REPLACED WITH A DIFFERENT BRAND (B BRAUN) SUCCESSFULLY. THERE WAS NO SERIOUS INJURY, COMPLICATIONS, OR DELAY CAUSED TO THE PATIENT. ONLY EXACERBATION OF HEADACHE DUE TO MULTIPLE ATTEMPTS.

  Patient problems: Headache

  MAUDE report 15958097 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103658. One submission often covers many models, so check the product and lot details in each record.

• Z-2364-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS;
• Z-1179-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1
• Z-1962-2018 · Apr 11, 2018 · Terminated
  SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500
• Z-2462-2015 · Jul 30, 2015 · Terminated
  PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound