CODMAN 82-1707Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886704040811), received between Jan 15, 2018 and Mar 9, 2023 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2023Break; Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16515868 ↗
• MalfunctionAug 30, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  1 OF 2 REPORTS. (SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS) OTHER MFG REPORT NUMBER: 2648988-2022-00017. A FACILITY REPORTED A LUMBAR CATHETER KIT (ID 821707) WAS USED FOR LUMBAR DRAINAGE TO EVACUATE EXCESS CSF ON AN ADULT PATIENT. DURING EXTERNAL LUMBAR DERIVATION, AFTER USE OF TROCAR (INCLUDED INTO THE KIT), AND THE INTRODUCTION OF DERIVATION CATHETER WITH MANDREL, IT WAS IMPOSSIBLE TO REMOVE THE MANDREL, WHICH FINALLY TORE THE CATHETER. THE MEDICAL TEAM IS WONDERING IF THE ENTIRE CATHETER WAS COMPLETELY REMOVED (DID NOT LOSE SOME PARTS). HOWEVER, THE PATIENT WAS NOT INJURED, BUT THE DYSFUNCTION LED TO INCREASED SURGERY TIME (CUSTOMER DID NOT KNOW FOR HOW LONG). THE CUSTOMER IS UNAWARE OF HOW THE PATIENT IS DOING NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319972 ↗
• MalfunctionJul 20, 2022Material Fragmentation; Material Fragmentation

  A FACILITY REPORTED A LUMBAR CATHETER (ID 821707) WAS USED ON A LUMBAR INSERTION AND THE TIP OF THE CATHETER SHREDDED APART ONCE IT WAS INSERTED INTO THE PATIENT. ALL VISIBLE PARTS WERE RECOVERED. NO PATIENT INJURY REPORTED. SURGICAL DELAY WAS REPORTED; HOWEVER, IT IS UNKNOWN FOR HOW LONG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065723 ↗
• MalfunctionJul 17, 2018Material Fragmentation; Material Fragmentation

  AS REPORTED BY THE OUS AFFILIATE, A LUMBAR CATHETER BROKE OFF IN THE PATIENT WHILE BEING IMPLANTED. IT IS SUSPECTED THAT THE DEVICE WAS NOT IRRIGATED ADEQUATELY AN RX EXAM WAS PERFORMED TO DETECT THE FRAGMENT IN THE PATIENT AND IT WAS DECIDED BY THE NEUROSURGEON NOT TO PERFORM A REVISION SURGERY. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM. PATIENT INFORMATION: NO INFORMATION. PATIENT IS NOT PART OF A CLINICAL STUDY. THIS IS NOT A REVISION OF ONE OR MORE IMPLANTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7696048 ↗
• MalfunctionApr 23, 2018Material Fragmentation; Activation, Positioning or Separation Problem; Material Fragmentation; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT WHILE BEING WITHDRAWN, A CODMAN LUMBAR CATHETER KIT BROKE WITH PART OF IT REMAINING IN THE PATIENT'S SPINAL CANAL (VERIFIED BY X-RAY AND MRI). THE REMNANT OF THE DRAIN WAS LEFT IN PLACE. NO NEUROLOGICAL OR OTHER SYMPTOMS WERE OBSERVED. ADDITIONAL INFORMATION RECEIVED 27MARCH2018: LUMBAR DRAIN WAS INSERTED USING STANDARD TECHNIQUE DURING LUMBAR DRAIN PLACEMENT PROCEDURE. THE INSERTION WAS WITHOUT COMPLICATIONS. PROBLEM OCCURRED WITH THE WITHDRAWAL OF THE LUMBAR DRAIN. IT WAS BEING REMOVED USING STANDARD TECHNIQUE, NO EXCESSIVE PULLING FORCES WERE APPLIED. PART OF THE DRAIN REMAINED IN THE SPINAL CANAL (VERIFIED BY X-RAY AND MRI). NO NEUROLOGICAL OR OTHER SYMPTOMS WERE OBSERVED. THE REMNANT OF THE DRAIN WAS LEFT IN PLACE. NO PATIENT CONSEQUENCE BY NOW. EVENT DATE: (B)(6) 2018. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7451052 ↗
• MalfunctionMar 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED ON A SPREADSHEET RECEIVED FROM INTEGRA ON 26FEBRUARY2018, A CODMAN LUMBAR CATHETER BECOMES DISCONNECTED FROM THE PORTAS AFTER IMPLANTATION, REQUIRING A REVISION. EVENT OCCURRED DURING PATIENT MONITORING, NOT DURING IMPLANTATION. DRAIN WAS REMOVED PREMATURELY TO AVOID RISK OF INFECTION THERE WERE NO REPORTS OF DELAY OR PATIENT HARM. THIS IS ONE OF THREE INCIDENTS REPORTED AT THE FACILITY (SAME PATIENT). THE OTHER TWO MDR#S ARE 2023988-2018-00006 AND 2023988-2018-00007. ADDITIONAL INFORMATION: 09FEB2018: ADDITIONAL INFORMATION REQUESTED: A QUESTIONNAIRE FROM THE DEPARTMENT OF HEALTH- THERAPEUTIC GOODS ADMINISTRATION WAS REQUESTED TO BE COMPLETED AND RETURNED WITHIN SEVEN DAYS. ON 4FEB2018: THE DEVICE IS NOT BEING RETURNED. ON 15FEB2018: ADDITIONAL INFO RECEIVED: YES, THE DRAINS WERE REMOVED AND REVISED AFTER IMPLANTATION. ISSUE DID NOT OCCUR DURING IMPLANTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7336342 ↗
• MalfunctionMar 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED ON A SPREADSHEET RECEIVED FROM INTEGRA ON 26FEBRUARY2018, A CODMAN LUMBAR CATHETER BECOMES DISCONNECTED FROM THE PORTAS AFTER IMPLANTATION, REQUIRING A REVISION SURGERY. EVENT OCCURRED DURING PATIENT MONITORING, NOT DURING CATHETER INSERTION. DRAIN WAS REMOVED PREMATURELY TO AVOID RISK OF INFECTION. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM. THIS IS ONE OF THREE INCIDENTS REPORTED AT THE FACILITY (SAME PATIENT). THE OTHER TWO ARE MDR#S ARE 2023988-2018-00006 AND 2023988-2018-00008. ADDITIONAL INFORMATION: ON 09FEB2018: ADDITIONAL INFORMATION REQUESTED: A QUESTIONNAIRE FROM THE DEPARTMENT OF HEALTH- THERAPEUTIC GOODS ADMINISTRATION WAS REQUESTED TO BE COMPLETED AND RETURNED WITHIN SEVEN DAYS. ON 14FEB2018 THE DEVICE IS NOT BEING RETURNED. ON 15FEB18 ADDITIONAL INFO RECEIVED: YES, THE DRAINS WERE REMOVED AND REVISED AFTER IMPLANTATION. ISSUE DID NOT OCCUR DURING IMPLANTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7336339 ↗
• MalfunctionMar 9, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED ON THE SPREADSHEET RECEIVED BY NATUS ON 14FEB2018, A CODMAN LUMBAR CATHETER EASILY BECOMES DISCONNECTED FROM THE PORTAS AS IT IS NOT CONNECTED BY LUER LOCK. THIS EVENT OCCURED AFTER IMPLANT; THE PATIENT HAD NO SYMPTOMS PRIOR TO THE SEPARATION, BUT THE DEVICE WAS REVISED. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM. CUSTOMER IS CONCERNED OF INCREASED OF SPINAL CORD INFECTION DUE TO LOSS OF ASEPSIS AS WELL AS RISK OF LOSS OF CEREBRO SPINAL FLUID CAUSING SIGNIFICANT NEUROLOGICAL COMPLICATIONS. NO MORE INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION: DEVICE WILL NOT BE RETURNED. A QUESTIONNAIRE FROM THE DEPARTMENT OF HEALTH - THERAPEUTIC GOODS ADMINISTRATION WAS REQUESTED TO BE COMPLETED AND RETURNED WITHIN SEVEN DAYS. ON 15FEB2018 ADDITIONAL INFO RECEIVED: YES, THE DRAINS WERE REMOVED AND REVISED AFTER IMPLANTATION. ISSUE DID NOT OCCUR DURING IMPLANTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7328706 ↗
• InjuryJan 15, 2018Break; Failure to Advance; Physical Resistance; Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED (B)(6) 2017 BY CODMAN TO NATUS: "AS REPORTED BY THE OUS AFFILIATE, A LUMBAR CATHETER COULD NOT BE INSERTED INTO THE SPINE CANAL BECAUSE OF RESISTANCE WITH ANOTHER DEVICE. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE DEVICE; HOWEVER, THE CATHETER BROKE/SEPARATED AND THE SEPARATED PORTION WAS RETAINED IN THE PATIENT. THERE IS NO REPORT OF ATTEMPT TO REMOVE THE RETAINED PORTION." AS NO FURTHER INFORMATION WAS PROVIDED RELATED TO THE PATIENT, THE EXTENT OF THE POSSIBLE DELAY IN SURGERY, AND WHETHER OR NOT REMEDIAL PROCEDURE WAS REQUIRED, ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7189971 ↗