NATUS LUMBAR CATHETER KIT NT821707Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00382830050531), received between Oct 8, 2024 and May 13, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

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

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Material Split, Cut or Torn

  PART NT821707 - THE TIP OF A LUMBER CATHETER SHEARED WHILE PLACING IN A PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157950 ↗
• MalfunctionJul 4, 2025Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  PER MD THE LUMBAR DRAIN IS PLACED BY ANESTHESIA TO PREVENT SPINAL CORD ISCHEMIA. UPON DRAIN REMOVAL BY ANESTHESIA IT WAS NOTED THE DRAIN TIP WAS NOT INTACT PROMPTING CT. PER MD IMAGING INDICATES RETAINED CATHETER TIP IS IN THE SUBCUTANEOUS TISSUE. INQUIRED ABOUT REMOVAL- DRAIN WAS PLACED IN A STERILE ENVIRONMENT AND DECISION PENDING REGARDING REMOVAL. IF PT STABLE WITH NO COMPLICATIONS FROM RETAINED DRAIN TIP WOULD PREFER TO REMOVE AS ELECTIVE CASE AFTER PT HAS STABILIZED. MD STATED HE WOULD PERFORM THE REMOVAL SINCE HE IS THE PRIMARY SURGEON FOR THE PT. PATIENT WENT FOR A CT THAT CONFIRM THAT IN FACT THE PIECE IS RETAINED AND REQUIRES SURGERY TO REMOVE. ON (B)(6) CT RESULTS: RETAINED 5.5 CM DURAL LONG LUMBAR DRAIN FRAGMENT AT THE L2-L3 LEVEL EXTENDING FROM THE POSTERIOR PARASPINAL SPACE VENTRALLY INTO THE BONY SPINAL CANAL AND LIKELY WITHIN THE THECAL SAC AT THE LEVEL OF L2-L3.

  Patient problems: Foreign Body In Patient

  MAUDE report 22402446 ↗
• MalfunctionJun 23, 2025Break; Material Fragmentation; Break; Material Fragmentation

  NT821707 - INSTANCES WHERE LUMBAR DRAINS HAVE HAD ISSUES WITH BREAKING/SHEARING AND NOT DRAINING WHILE CLINICIANS ARE INTERACTING WITH THEM FOR PATIENTS. EVENT 1/3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311815 ↗
• MalfunctionJun 23, 2025Break; Material Fragmentation; Break; Material Fragmentation

  NT821707 - INSTANCES WHERE LUMBAR DRAINS HAVE HAD ISSUES WITH BREAKING/SHEARING AND NOT DRAINING WHILE CLINICIANS ARE INTERACTING WITH THEM FOR PATIENTS. EVENT 3/3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311586 ↗
• MalfunctionJun 23, 2025Break; Material Fragmentation; Break; Material Fragmentation

  NT821707 - INSTANCES WHERE LUMBAR DRAINS HAVE HAD ISSUES WITH BREAKING/SHEARING AND NOT DRAINING WHILE CLINICIANS ARE INTERACTING WITH THEM FOR PATIENTS. EVENT 2/3

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311536 ↗
• MalfunctionJun 13, 2025Material Fragmentation; Material Fragmentation

  NT821707 - ON [REDACTED], IR [INTERVENTIONAL RADIOLOGY] PHYSICIAN REPORTED UNSUCCESSFUL FLUOROSCOPICALLY GUIDED LUMBAR DRAIN PLACEMENT COMPLICATED BY A SHORT FRAGMENT OF DISTAL DRAIN SHEARED OFF INTO POSTERIOR EPIDURAL SPACE (SMALL FOREIGN BODY). CT CATH FRAGMENT RETAINED 2.5CM AND DIAMETER OF 0.2CM IN RIGHT DORSAL EPIDURAL SPACED. LEVEL L3-4. PROCEDURE ABORTED AND NO SAFE WAY OF PERCUTANEOUS RETRIEVAL. DISCUSSED WITH NEUROLOGY MD TEAM. DISCUSSED WITH PATIENT AND SEVERAL FAMILY MEMBERS AT GREAT LENGTH. ON THE NEXT DAY [REDACTED], PT WAS TAKEN TO SURGERY FOR CSF [CEREBROSPINAL FLUID] LEAK REPAIR (UNRELATED TO THIS EVENT) AND NEUROSURGEON WAS ABLE TO REMOVE THE RETAINED DRAIN FRAGMENT, BUT IT WAS UNFORTUNATELY DISCARDED BY SURGERY TEAM. NO HARM OR DEVIATION IN CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207557 ↗
• MalfunctionJun 13, 2025Use of Device Problem; Use of Device Problem

  NT821707 - CHALLENGING LUMBAR DRAIN PLACEMENT. THE TIP OF THE 9CM TUOHY NEEDLE IN THE KIT MAY GET DULLED OR CURL BACKWARDS WHEN PLACING THE DRAIN. NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206859 ↗
• MalfunctionJun 13, 2025Use of Device Problem; Use of Device Problem

  NT821707 - CHALLENGING LUMBAR DRAIN PLACEMENT. THE TIP OF THE 9CM TUOHY NEEDLE IN THE KIT MAY GET DULLED OR CURL BACKWARDS WHEN PLACING THE DRAIN. NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206858 ↗
• MalfunctionJun 5, 2025Entrapment of Device; Material Fragmentation

  ON [REDACTED], IR [INTERVENTIONAL RADIOLOGY] PHYSICIAN REPORTED UNSUCCESSFUL FLUOROSCOPICALLY GUIDED LUMBAR DRAIN PLACEMENT COMPLICATED BY A SHORT FRAGMENT OF DISTAL DRAIN SHEARED OFF INTO POSTERIOR EPIDURAL SPACE (SMALL FOREIGN BODY). CT CATH FRAGMENT RETAINED 2.5CM AND DIAMETER OF 0.2CM IN RIGHT DORSAL EPIDURAL SPACED. LEVEL L3-4. PROCEDURE ABORTED AND NO SAFE WAY OF PERCUTANEOUS RETRIEVAL. DISCUSSED WITH NEUROLOGY MD TEAM. DISCUSSED WITH PATIENT AND SEVERAL FAMILY MEMBERS AT GREAT LENGTH. ON THE NEXT DAY [REDACTED], PT WAS TAKEN TO SURGERY FOR CSF [CEREBROSPINAL FLUID] LEAK REPAIR (UNRELATED TO THIS EVENT) AND NEUROSURGEON WAS ABLE TO REMOVE THE RETAINED DRAIN FRAGMENT, BUT IT WAS UNFORTUNATELY DISCARDED BY SURGERY TEAM. NO HARM OR DEVIATION IN CARE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 22148640 ↗
• MalfunctionMay 14, 2025Break; Break

  ON NT821707 - THE DOCTOR PLACED A LUMBAR CATHETER, THE CATHETER WAS PRIMED WITH SALINE. UPON REMOVAL, CATHETER WAS DIFFICULT TO PULL BACK. THE CATHETER SHEERED. CT IMAGING OBTAINED, TWO PIECES REMAIN IN PATIENT. NEUROSURGERY CONSULTED TO DETERMINE IF SURGERY FOR REMOVAL IS NEEDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22023337 ↗
• MalfunctionApr 27, 2025Break; Break

  WHEN INSERTING THE LUMBAR DRAIN, THE PATIENT FELT NUMBNESS DOWN HER LEG. THE DRAIN WAS RETRACTED TO REPOSITION. UPON REMOVAL OF THE DRAIN, IT WAS DISCOVERED PART OF THE END OF THE CATHETER WAS MISSING. (APPARENTLY SHEARED OFF BY ACCESS NEEDLE. THEY REMOVED THE ACCESS NEEDLE TO CHECK FOR MISSING FRAGMENT BUT DID NOT SEE IT. A NEW ACCESS NEEDLE WAS USED, AND NEW LUMBAR DRAIN WAS PLACED.

  Patient problems: Foreign Body In Patient; Numbness

  MAUDE report 21915993 ↗
• MalfunctionApr 14, 2025Break; Break

  NT821707 LUMBAR CATHETER PLACED IN IR SUITE. THE NEUROSURGEON WENT TO REMOVE CATHETER IN OR AND THE CATHETER SPLINTERED INTO A FEW PIECES - OVER 70-YEAR-OLD MALE WITH HISTORY OF RECTAL CANCER STATUS POST COLECTOMY BEING WORKED UP FOR POSSIBLE NORMAL PRESSURE HYDROCEPHALOUS. PATIENT UNDERWENT FLUOROSCOPIC GUIDED INTRATHECAL DRAIN PLACEMENT. POST PROCEDURE THERE WAS CONCERN THAT THE DRAIN WAS NOT DRAINING. PATIENT WAS BROUGHT BACK TO PROCEDURE AND UNDERWENT FLUOROSCOPIC GUIDED INTRATHECAL DRAIN EVALUATION WITH REMOVAL THAT SAME DAY. SEGMENTAL DEFECT WITHIN THE LUMBAR DRAIN CATHETER WAS IDENTIFIED. DURING REMOVAL THE CATHETER BROKE. THE INTRATHECAL SEGMENT WAS SUCCESSFULLY REMOVED. NO KNOWN HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21832420 ↗
• MalfunctionOct 23, 2024

  OVER 70-YEAR-OLD MALE WITH HISTORY OF RECTAL CANCER STATUS POST COLECTOMY BEING WORKED UP FOR POSSIBLE NORMAL PRESSURE HYDROCEPHALOUS. PATIENT UNDERWENT FLUOROSCOPIC GUIDED INTRATHECAL DRAIN PLACEMENT. POST PROCEDURE THERE WAS CONCERN THAT THE DRAIN WAS NOT DRAINING. PATIENT WAS BROUGHT BACK TO PROCEDURE AND UNDERWENT FLUOROSCOPIC GUIDED INTRATHECAL DRAIN EVALUATION WITH REMOVAL THAT SAME DAY. SEGMENTAL DEFECT WITHIN THE LUMBAR DRAIN CATHETER WAS IDENTIFIED. DURING REMOVAL THE CATHETER BROKE. THE INTRATHECAL SEGMENT WAS SUCCESSFULLY REMOVED. NO KNOWN HARM TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20513874 ↗
• MalfunctionOct 22, 2024Break; Device Reprocessing Problem; Break; Device Reprocessing Problem

  NT821707, DRAINAGE KIT, LUMBAR WHILE PERFORMING A LUMBAR DRAIN AT THE BEDSIDE - A PIECE OF THE SOFT TUBING WAS SHEARED AND LEFT IN THE THECAL SAC. THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; DEVICE WAS HARD TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509422 ↗
• MalfunctionOct 22, 2024Break; Device Reprocessing Problem; Break; Device Reprocessing Problem

  PART 821707 CODMAN* LUMBAR CATHETER KIT REOPERATIVE PLACEMENT OF LUMBAR DRAIN - ENCOUNTERED RESISTANCE DURING INITIAL PLACEMENT, LUMBAR DRAIN REMOVED AND NOTED TO HAVE THE END OF THE TUBING SHEARED OFF, <1MM, WIRE REMAINED INTACT. SECOND LUMBAR DRAIN PLACED SUCCESSFULLY. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509413 ↗
• MalfunctionOct 22, 2024Break; Device Reprocessing Problem; Break; Device Reprocessing Problem

  PART NT821707 - ON (B)(6) 2024 SINGLE ATTEMPT OF REMOVAL AND ON INSPECTION, TIP OF CATHETER WAS NOTED TO BE SHEARED JUST DISTAL TO THE LAST DRAINAGE HOLES ON THE CATHETER. NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509133 ↗
• MalfunctionOct 8, 2024Break; Break

  PART NT821707, DRAINAGE KIT, LUMBAR - OVER 70-YEAR-OLD MALE WITH HISTORY OF RECTAL CANCER STATUS POST COLECTOMY BEING WORKED UP FOR POSSIBLE NORMAL PRESSURE HYDROCEPHALOUS. PATIENT UNDERWENT FLUOROSCOPIC GUIDED INTRATHECAL DRAIN PLACEMENT. POST PROCEDURE THERE WAS CONCERN THAT THE DRAIN WAS NOT DRAINING. PATIENT WAS BROUGHT BACK TO PROCEDURE AND UNDERWENT FLUOROSCOPIC GUIDED INTRATHECAL DRAIN EVALUATION WITH REMOVAL THAT SAME DAY. SEGMENTAL DEFECT WITHIN THE LUMBAR DRAIN CATHETER WAS IDENTIFIED. DURING REMOVAL THE CATHETER BROKE. THE INTRATHECAL SEGMENT WAS SUCCESSFULLY REMOVED. NO KNOWN HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20401960 ↗
• MalfunctionOct 8, 2024Break; Break

  PART: NT821707 - LUMBAR DRAIN CATHETER TIP BROKE OFF. UPON REMOVAL OF LUMBAR DRAIN, FRAGMENT REPORTED RETAINED PER CT AT L3 L4. DEVICE EMBEDDED IN TISSUE OR PLAQUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20400244 ↗