CODMAN BACTISEALRecalls & reported problems across all models
Integra Lifesciences Production Corporation · 13 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name at least one CODMAN BACTISEAL model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 136
- Deaths reported
- 2
- Injuries reported
- 103
- Recalls
- 3
We found 13 models of CODMAN BACTISEAL by Integra Lifesciences Production Corporation in the FDA's device registry (GUDID). Together they are named in 136 adverse event reports in the FDA's MAUDE database, received between Oct 10, 2021 and Aug 21, 2026 — classified as 2 deaths, 103 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (36 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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
Reports received per month, all models
CODMAN BACTISEAL 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.
- May 7, 2024Class IIOpen, Classified
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
Z-2138-2024 · Root cause: Process control · Recall details · FDA record ↗
- May 7, 2024Class IIOpen, Classified
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
Z-2137-2024 · Root cause: Process control · Recall details · FDA record ↗
- May 7, 2024Class IIOpen, Classified
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
Z-2136-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported CODMAN BACTISEAL problems
Device problems
- Insufficient Device Problem Information36
- Obstruction of Flow35
- Fluid/Blood Leak15
- Migration11
- Adverse Event Without Identified Device or Use Problem6
- Device Dislodged or Dislocated6
- Break4
- No Flow4
Patient problems
- Insufficient Information41
- No Clinical Signs, Symptoms or Conditions20
- Unspecified Infection20
- Cerebral Ventriculomegaly13
- Cerebrospinal Fluid Leakage12
- Fever9
- Headache7
- Hydrocephalus7
CODMAN BACTISEAL models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CODMAN® BACTISEAL® 821749Shunt, central nervous system and components1 recall12 reports
- CODMAN® BACTISEAL® 821745Shunt, central nervous system and components1 recall11 reports
- CODMAN® BACTISEAL® 823072Shunt, central nervous system and components2 deaths53 reports
- CODMAN® BACTISEAL® 821750Shunt, central nervous system and components1 recall1 report
- CODMAN® BACTISEAL® 823073Shunt, central nervous system and components16 reports
- CODMAN® BACTISEAL® 823074Shunt, central nervous system and components14 reports
- CODMAN® BACTISEAL® NS0339CATHETER, VENTRICULAR6 reports
- CODMAN® BACTISEAL® 823072Shunt, central nervous system and components6 reports
- CODMAN® BACTISEAL® NS0340CATHETER, VENTRICULAR5 reports
- CODMAN® BACTISEAL® 823074Shunt, central nervous system and components5 reports
- CODMAN® BACTISEAL® NS0338CATHETER, VENTRICULAR3 reports
- CODMAN® BACTISEAL® 823073Shunt, central nervous system and components3 reports
- CODMAN® BACTISEAL® NS0343Shunt, central nervous system and components1 report
Recent CODMAN BACTISEAL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 21, 2026Device Dislodged or Dislocated; Migration
Patient problems: Insufficient Information
MAUDE report 50374206 ↗InjuryAug 21, 2026Device Dislodged or Dislocated; Migration
6 of 7 reports (Same facility/surgeon, 3 patients, 7 revisions). Other Mfg report numbers:3013886523-2026-002113013886523-2026-002123013886523-2026-002133013886523-2026-002143013886523-2026-002153013886523-2026-00217This report is for Patient 3/revision 1.A facility reported that in the last 4 months he needed to do 7 revisions after a peritoneal catheter luxated and went out of the peritoneum (distal catheter migration) this with 3 different patients 1 patient needed 3 revisions, and 2 patients needed 2 revisions. 2 patients were somewhat obese, 1 had +/- normal weight. Therefore, the catheter was explanted.No additional information has been provided after several attempts.
Patient problems: Insufficient Information
MAUDE report 50374202 ↗InjuryAug 21, 2026Device Dislodged or Dislocated; Migration
4 of 7 reports (Same facility/surgeon, 3 patients, 7 revisions). Other Mfg report numbers:3013886523-2026-002113013886523-2026-002123013886523-2026-002133013886523-2026-002153013886523-2026-002163013886523-2026-00217This report is for Patient 2/revision 1.A facility reported that in the last 4 months he needed to do 7 revisions after a peritoneal catheter luxated and went out of the peritoneum (distal catheter migration) this with 3 different patients 1 patient needed 3 revisions, and 2 patients needed 2 revisions. 2 patients were somewhat obese, 1 had +/- normal weight. Therefore, the catheter was explanted.No additional information has been provided after several attempts.
Patient problems: Insufficient Information
MAUDE report 50374199 ↗InjuryAug 21, 2026Device Dislodged or Dislocated; Migration
3 of 7 reports (Same facility/surgeon, 3 patients, 7 revisions). Other Mfg report numbers:3013886523-2026-002113013886523-2026-002123013886523-2026-002143013886523-2026-002153013886523-2026-002163013886523-2026-00217This report is for Patient 1/revision 3.A facility reported that in the last 4 months he needed to do 7 revisions after a peritoneal catheter luxated and went out of the peritoneum (distal catheter migration) this with 3 different patients 1 patient needed 3 revisions, and 2 patients needed 2 revisions. 2 patients were somewhat obese, 1 had +/- normal weight. Therefore, the catheter was explanted.No additional information has been provided after several attempts.
Patient problems: Insufficient Information
MAUDE report 50374198 ↗InjuryAug 21, 2026Device Dislodged or Dislocated; Migration
2 of 7 reports (Same facility/surgeon, 3 patients, 7 revisions). Other Mfg report numbers:3013886523-2026-00211,3013886523-2026-00213,3013886523-2026-00214,3013886523-2026-00215,3013886523-2026-00216,3013886523-2026-00217.This report is for Patient 1/revision 2.A facility reported that in the last 4 months he needed to do 7 revisions after a peritoneal catheter luxated and went out of the peritoneum (distal catheter migration) this with 3 different patients 1 patient needed 3 revisions, and 2 patients needed 2 revisions. 2 patients were somewhat obese, 1 had +/- normal weight. Therefore, the catheter was explanted.No additional information has been provided after several attempts.
Patient problems: Insufficient Information
MAUDE report 50374197 ↗InjuryAug 21, 2026Device Dislodged or Dislocated; Migration
1 of 7 reports (Same facility/surgeon, 3 patients, 7 revisions). Other Mfg report numbers:3013886523-2026-00212,3013886523-2026-00213,3013886523-2026-00214,3013886523-2026-00215,3013886523-2026-00216,3013886523-2026-00217.This report is for Patient 1/revision 1.A facility reported that in the last 4 months he needed to do 7 revisions after a peritoneal catheter luxated and went out of the peritoneum (distal catheter migration) this with 3 different patients 1 patient needed 3 revisions, and 2 patients needed 2 revisions. 2 patients were somewhat obese, 1 had +/- normal weight. Therefore, the catheter was explanted.No additional information has been provided after several attempts.
Patient problems: Insufficient Information
MAUDE report 50374196 ↗MalfunctionJul 27, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Headache
MAUDE report 50024260 ↗InjuryJun 12, 2026Insufficient Device Problem Information
InjuryMay 12, 2026Obstruction of Flow
A FACILITY REPORTED A BACTISEAL CATHETER (ID: 823072) AND A CERTAS VALVE WERE IMPLANTED VIA VENTRICULOPERITONEAL (V-P) SHUNT. THE VALVE AND THE BACTISEAL CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2026 DUE TO SUSPICION OF OBSTRUCTION. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT HAD ANY SIGNS AND SYMPTOMS DUE TO PRODUCT FAILURE.
Patient problems: Insufficient Information
MAUDE report 25148810 ↗MalfunctionMay 1, 2026Improper or Incorrect Procedure or Method
A FACILITY REPORTED THE MEDICAL TEAM IMPLANTED AN EXPIRED BACTISEAL CATHETER (ID 823072). IT WAS USED DURING SURGERY ON (B)(6) 2026 WITH EXPIRY DATE FEBRUARY 28, 2026. NO OTHER APPARENT PROBLEMS OCCURRED WITH THE PATIENT OR DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056531 ↗InjuryMay 1, 2026Obstruction of Flow
MalfunctionApr 3, 2026Insufficient Device Problem Information
A FACILITY REPORTED AN EXPIRED BACTISEAL CATHETER (ID: 821749) WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.
Patient problems: Insufficient Information
MAUDE report 24781391 ↗MalfunctionMar 20, 2026Crack; Fluid/Blood Leak
A FACILITY REPORTED AN EVD BEGAN TO LEAK AND ON INSPECTION MEDICAL STAFF FOUND A LINEAR CUT IN THE CATHETER. THERE WAS NO HARM TO THE PATIENT AND THE EVD HAS BEEN FUNCTIONING NORMALLY FOR OVER 12 HOURS PRIOR TO THE LEAK.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 24647985 ↗InjuryMar 6, 2026Obstruction of Flow
A FACILITY REPORTED A CERTAS VALVE (ID 828814) AND BACTISEAL PERITONEAL CATHETER (ID 823074) WERE IMPLANTED IN 2023 DUE TO UNKNOWN REASON VIA VENTRICULOATRIAL (VA) SHUNT AT AN UNKNOWN SETTING. ON (B)(6) 2026, THE VALVE AND CATHETER WERE REMOVED DUE TO SUSPICION OF OBSTRUCTION. ACCORDING TO THE INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO THE SUSPICION OF OBSTRUCTION. IT IS ALSO UNKNOWN WHAT THE CURRENT STATUS OF THE PATIENT IS.
Patient problems: Insufficient Information
MAUDE report 24532744 ↗InjuryFeb 27, 2026Fluid/Blood Leak
A FACILITY REPORTED A BACTISEAL CATHETER (ID 821749) WAS IMPLANTED ON (B)(6) 2026. ON (B)(6) 2026, A LEAKAGE WAS OBSERVED AT THE CATHETER INTERFACE, AND IT WAS REMOVED, NOT REPLACED. THE PATIENT'S CONDITION REMAINED STABLE.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 24469594 ↗
Other Integra Lifesciences Production Corporation products
All Integra Lifesciences Production Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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