SwartzRecalls & reported problems across all models
St. Jude Medical, Inc. · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,383
- Deaths reported
- 17
- Injuries reported
- 177
- Recalls
- 0
We found 17 models of Swartz by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,383 adverse event reports in the FDA's MAUDE database, received between Jun 12, 2018 and Sep 29, 2026 — classified as 17 deaths, 177 injuries, 1,189 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (474 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. 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
Most reported Swartz problems
Device problems
- Gas/Air Leak474
- Fluid/Blood Leak409
- Flaked151
- Adverse Event Without Identified Device or Use Problem121
- Material Puncture/Hole120
- Difficult to Insert68
- Material Separation39
- Fracture23
Patient problems
- No Clinical Signs, Symptoms or Conditions997
- No Consequences Or Impact To Patient220
- Cardiac Perforation94
- Arrhythmia20
- Air Embolism19
- Foreign Body In Patient13
- Death11
- Stroke/CVA10
Swartz models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Swartz™ 407451INTRODUCER, CATHETER5 deaths728 reports
- Swartz™ 407453INTRODUCER, CATHETER4 deaths287 reports
- Swartz™ 407449INTRODUCER, CATHETER3 deaths130 reports
- Swartz™ 407439INTRODUCER, CATHETER5 deaths115 reports
- Swartz™ 407362INTRODUCER, CATHETER56 reports
- Swartz™ 407360INTRODUCER, CATHETER14 reports
- Swartz™ 407455INTRODUCER, CATHETER11 reports
- Swartz™ 407358INTRODUCER, CATHETER8 reports
- Swartz™ 407452INTRODUCER, CATHETER7 reports
- Swartz™ 407450INTRODUCER, CATHETER6 reports
- Swartz™ 407454INTRODUCER, CATHETER6 reports
- Swartz™ 407456INTRODUCER, CATHETER5 reports
- Swartz™ 407356INTRODUCER, CATHETER3 reports
- Swartz™ 407366INTRODUCER, CATHETER3 reports
- Swartz™ 407441INTRODUCER, CATHETER2 reports
- Swartz™ 407364INTRODUCER, CATHETER1 report
- Swartz™ 407446INTRODUCER, CATHETER1 report
Recent Swartz adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Flaked
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939098 ↗MalfunctionSep 28, 2026Gas/Air Leak
During the atrial fibrillation procedure, an air leak was noted. The introducer was replaced and the procedure was completed with no adverse consequences to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916432 ↗MalfunctionSep 25, 2026Flaked
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903208 ↗DeathSep 24, 2026Difficult to Insert; Improper or Incorrect Procedure or Method; Material Twisted/Bent
During a PFA procedure, air ingress, ST elevation, bradycardia, and cerebral hypoxia occurred which resulted in the patient transferring to the ICU and receiving hyperbaric therapy twice. The patient later passed away in the neurology ICU. For the procedure, the patient was sedated with fentanyl and remiMizolam. The transseptal puncture progressed normally with a jump to fosa ovalis and an expected IBP curve form for LA pressure. After the transseptal puncture, the SL0 guidewire was placed in the LSPV of the left atrium. The dilator and SL0 sheath were removed from the patient. The Agilis 13F and dilator were then advanced over the SL0 guidewire into the IVC. However, resistance was felt before reaching the heart. Fluoroscopy noted that the SL0 guidewire was kinked below the diaphragm. The Agilis 13F and dilator were removed from the IVC. The SL0 sheath and dilator were flushed, re-assembled, and re-inserted into the IVC along the guidewire. The SL0 and dilator also could not pass the kinked guidewire. The SL0 and dilator were removed again. The SL0 sheath was flushed again, and only the SL0 sheath was advanced over the guidewire without the dilator. The SL0 was able to advance pas
Patient problems: Air Embolism; Arrhythmia; Stroke/CVA
MAUDE report 50889804 ↗MalfunctionSep 24, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50887840 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
During the atrial fibrillation procedure, a cardiac tamponade requiring a thoracotomy was noted while performing left atrial mapping after transseptal puncture. Transseptal puncture was performed using a Swartz sheath and RF needle. An HD Grid catheter was inserted and left atrial mapping was being performed when the patients' blood pressure was noted to be dropping and a cardiac tamponade was confirmed via echocardiography. Hemostasis was achieved via a thoracotomy. The procedure was completed without replacing the device. The patient is stable and recovered.
Patient problems: Cardiac Perforation
MAUDE report 50885527 ↗MalfunctionSep 24, 2026Gas/Air Leak
During an atrial fibrillation procedure, air was introduced from the Swartz SL0 sheath. It was noted that a syringe was attached to the side port to aspirate when the air entered the sheath. The sheath was exchanged, and the procedure was completed with no adverse patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882270 ↗MalfunctionSep 23, 2026Gas/Air Leak
During the atrial fibrillation procedure, an air leak was noted on the Swartz sheath. The Swartz sheath was exchanged, and the procedure was completed with no adverse patient health consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869821 ↗MalfunctionSep 22, 2026Difficult to Insert; Material Puncture/Hole
During the atrial fibrillation procedure, it was noted that the Swartz sheath was punctured by the BRK needle during transseptal. While initiating transseptal puncture with the BRK needle it was noted that there was resistance in the sheath. The entire assembly was withdrawn from the patient, and it was noted that the BRK needle had punctured the Swartz sheath. The Swartz sheath was exchanged, and transseptal puncture was completed successfully. The procedure was completed with no adverse patient health consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860186 ↗MalfunctionSep 22, 2026Gas/Air Leak
During a paroxysmal supraventricular tachycardia procedure, an air leak was noted on the Swartz sheath. The Swartz sheath was exchanged, and the procedure was completed with no adverse patient health consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858612 ↗MalfunctionSep 22, 2026Gas/Air Leak
During an atrial fibrillation procedure, after performing the transseptal puncture, while aspirating blood through the tube, air bubbles were aspirated. The sheath was replaced to resolve the issue. The procedure was completed with no adverse patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854640 ↗MalfunctionSep 1, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543705 ↗InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem
During the MitraClip procedure for mitral regurgitation, a pericardial effusion was noted after transseptal puncture with a BRK needle and advancement of the Swartz sheath. Transseptal puncture was performed with the BRK needle and prior to inserting the MitraClip devices, a pericardial effusion was noted after advancing the sheath into the left atrium. When the pericardial effusion was noted, the patient experiences a drop in blood pressure. The procedure was stopped, and a pericardiocentesis was performed. An attempt was made to continue the MitraClip procedure; however, the patient was hemodynamically unstable and the physician preferred to remove the device and stop the procedure again. The patient was stable after the procedure and there were no further adverse patient health consequences.
Patient problems: Cardiac Perforation
MAUDE report 50381149 ↗MalfunctionAug 19, 2026Gas/Air Leak
During an atrial fibrillation procedure, an abnormally large amount of air was aspirated from the Swartz SL0 introducer. It was noted that even after repeated aspiration, all of the air could not be removed from the introducer. The introducer was replaced, and the procedure was completed with no adverse consequences to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50321513 ↗MalfunctionAug 13, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241051 ↗
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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