SJMRecalls & reported problems across all models
St. Jude Medical, Inc. · 31 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one SJM model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 159
- Deaths reported
- 5
- Injuries reported
- 129
- Recalls
- 2
We found 31 models of SJM by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 159 adverse event reports in the FDA's MAUDE database, received between Sep 26, 2018 and Mar 24, 2026 — classified as 5 deaths, 129 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Lack of Effect” (12 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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
SJM 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.
- Oct 9, 2025Open, Classified
The impacted lot may not meet the required tensile strength specification.
Z-0532-2026 · Root cause: Process control · Recall details · FDA record ↗
- Oct 9, 2025Open, Classified
The impacted lot may not meet the required tensile strength specification.
Z-0531-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported SJM problems
Device problems
- Adverse Event Without Identified Device or Use Problem90
- Lack of Effect12
- High impedance11
- Difficult to Insert9
- Difficult or Delayed Separation7
- Fracture6
- Backflow5
- Improper or Incorrect Procedure or Method4
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Mitral Valve Insufficiency/ Regurgitation18
- Pneumothorax16
- Hemorrhage/Blood Loss/Bleeding15
- No Consequences Or Impact To Patient14
- Inadequate Pain Relief13
- Atrial Fibrillation11
- Coagulation Disorder11
SJM models
31 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SJM™ C0510PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 recall0 reports
- SJM™ C0914PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 recall0 reports
- SJM™ RSAR-30RING, ANNULOPLASTY1 death20 reports
- SJM™ SARP-30RING, ANNULOPLASTY15 reports
- SJM™ 3383STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF15 reports
- SJM™ RSAR-32RING, ANNULOPLASTY1 death13 reports
- SJM™ RSAR-28RING, ANNULOPLASTY1 death11 reports
- SJM™ 405104INTRODUCER, CATHETER11 reports
- SJM™ SARP-28RING, ANNULOPLASTY10 reports
- SJM™ RSAR-34RING, ANNULOPLASTY8 reports
- SJM™ 405112INTRODUCER, CATHETER8 reports
- SJM™ SARP-32RING, ANNULOPLASTY7 reports
- SJM™ 405154INTRODUCER, CATHETER6 reports
- SJM™ RSAR-26RING, ANNULOPLASTY1 death5 reports
- SJM™ 405108INTRODUCER, CATHETER1 death4 reports
- SJM™ 3013STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)4 reports
- SJM™ G402047CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 reports
- SJM™ SARP-26RING, ANNULOPLASTY2 reports
- SJM™ SARP-34RING, ANNULOPLASTY2 reports
- SJM™ 2316STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 reports
- SJM™ 3032STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 reports
- SJM™ 1105STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 reports
- SJM™ C0205PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 report
- SJM™ SARP-38RING, ANNULOPLASTY1 report
- SJM™ 405116INTRODUCER, CATHETER1 report
- SJM™ 405122INTRODUCER, CATHETER1 report
- SJM™ 405153INTRODUCER, CATHETER1 report
- SJM™ 405254INTRODUCER, CATHETER1 report
- SJM™ 1105STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 report
- SJM™ 3599STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 report
- SJM™ 1314NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
Recent SJM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (b)(6) 2024, A SJM PERICARDIAL PATCH WAS IMPLANTED IN THE PATIENT. ON (b)(6)2025, THE PATCH GOT EXPLANTED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24675763 ↗InjuryAug 8, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE LEAD EXTENSIONS ON (B)(6) 2025. THE IMPEDANCES RESOLVED. THERAPY WAS RESTORED POST-OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 22756939 ↗InjuryAug 8, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE LEAD EXTENSIONS ON (B)(6) 2025. THE IMPEDANCES RESOLVED. THERAPY WAS RESTORED POST-OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 22756936 ↗InjuryMay 23, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT DURING A PROCEDURE AN EXPIRED MLTC CABLE WAS USED. NO ADVERSE EFFECTS HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22080339 ↗MalfunctionNov 27, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED DURING A TRIAL IMPLANT PROCEDURE AN EXPIRED STERILE PRODUCT WAS USED, THE EXPIRED HEADER WAS DISPOSED AT THE END OF TRIAL APPT. NO REPORTED COMPLICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20801316 ↗InjuryOct 24, 2024High impedance; High impedance
IT WAS REPORTED, DURING THE 07 OCT 2024 IPG REPLACEMENT (RELATED MANUFACTURER REFERENCE NUMBER: (B)(4), THE LEAD WAS FOUND TO HAVE ALL HIGH IMPEDANCES. AS SUCH, THE EXTENSION WAS REMOVED AND IT WAS REVEALED THE IMPEDANCES WOULD CLEAR AFTER THE REMOVAL OF THE EXTENSION. AS A RESULT, THE EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant
MAUDE report 20527722 ↗InjuryAug 14, 2024High impedance; High impedance
ADDITIONAL INFORMATION WAS OBTAINED, REVEALING THAT THE PATIENT HAD EXPERIENCED INEFFECTIVE THERAPY, PRIOR TO SURGERY.
Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions
MAUDE report 19980650 ↗InjuryAug 14, 2024High impedance; High impedance
ADDITIONAL INFORMATION WAS OBTAINED, REVEALING THAT THE PATIENT HAD EXPERIENCED INEFFECTIVE THERAPY, PRIOR TO SURGERY.
Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions
MAUDE report 19980646 ↗MalfunctionJun 26, 2024Gas/Air Leak; Gas/Air Leak
DURING A VEIN OF MARSHALL ALCOHOL ABLATION PROCEDURE, AN AIR LEAK OCCURRED. THE INTRODUCER WAS IN THE ENDOCARDIAL SPACE. ACCESS WAS OBTAINED THROUGH THE INTERNAL JUGULAR (IJ) AND THE INTRODUCER WAS BEING USED TO GAIN ACCESS TO THE CORONARY SINUS (CS) OSTIUM FROM ABOVE. WHILE IN THE HEART, THE PHYSICIAN WAS "PULLING BACK" AIR ONLY (NOT BLOOD) THROUGH THE SHEATH. IT WAS CONFIRMED THAT THE DEVICE WAS IN THE HEART, NOT THE LUNGS. THE PHYSICIAN FELT THAT THE HEMOSTASIS VALVE WAS COMPROMISED, AND THE AIR WAS BEING PULLED THROUGH THE VALVE. UPON REMOVING THE INTRODUCER FROM THE PATIENT, THE PHYSICIAN HAD TROUBLE RE-INSERTING THE DILATOR INTO THE SHEATH. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19616314 ↗InjuryJun 1, 2024High impedance; High impedance
IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON 3 CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD EXTENSION WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED. NOTE : IT IS UNKNOWN WHICH EXTENSION IS RELATED TO THIS ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 19444259 ↗MalfunctionFeb 6, 2024Fracture; Fracture
IT WAS REPORTED THAT A LACERATION WAS NOTED ON THE DISTAL END OF THE INTRODUCER, APPROXIMATELY 4CM BEFORE ENTERING THE VEIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18651745 ↗InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DURING A LEAD REPLACEMENT PROCEDURE (RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2023-07067 ) ON (B)(6) 2023, THE PATIENT EXPERIENCED A CSF LEAK WHEN THE DOCTOR ATTEMPTED TO PLACE THE EPIDURAL NEEDLE. THE DOCTOR ACCESSED A DIFFERENT LEVEL AND COMPLETED THE IMPLANT. IN RECOVERY, THE PATIENT EXPERIENCED HEADACHE. REPORTEDLY, THE PATIENT WAS INSTRUCTED TO LAY FLAT WHICH RESOLVED THE HEADACHE.
Patient problems: Cerebrospinal Fluid Leakage; Headache
MAUDE report 18539921 ↗MalfunctionJan 3, 2024Lack of Effect; Lack of Effect
IT WAS REPORTED THAT ON 12 DECEMBER 2023, A 32MM SEGIUN MITRAL VALVE RING WAS CHOSEN FOR IMPLANTATION. AFTER IMPLANTATION, IT WAS FOUND BY INTRAOPERATIVE ULTRASOUND THAT THERE WAS STILL MODERATE MITRAL REGURGITATION. THE SEGIUN RING WAS REMOVED AND A MITRAL VALVE REPLACEMENT PROCEDURE WAS PERFORMED. THE OPERATION WAS EXTENDED BY 30 MINUTES, BUT THERE WAS NO PATIENT EFFECTS DUE TO THE DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT IS REPORTED TO BE STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18439957 ↗InjuryDec 7, 2023High impedance; High impedance
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-05831, 1627487-2023-05489. IT WAS REPORTED THAT, DURING A LEAD REVISION PROCEDURE ON (B)(6) 2023, BOTH LEAD EXTENSIONS WERE FOUND TO HAVE HIGH IMPEDANCES. AS A RESULT, BOTH LEAD EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 18288668 ↗InjuryDec 7, 2023High impedance; High impedance
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-05830, 1627487-2023-05489. IT WAS REPORTED THAT, DURING A LEAD REVISION PROCEDURE ON (B)(6) 2023, BOTH LEAD EXTENSIONS WERE FOUND TO HAVE HIGH IMPEDANCES. AS A RESULT, BOTH LEAD EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 18288666 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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