NA C315HIS02 (UDI 00613994749925)Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00613994749925), received between Oct 6, 2017 and Nov 19, 2021 — classified as 4 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Break” (30 reports).

1 other recall cover devices cleared under the same FDA submission (K101885); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER EXHIBITED A FRACTURE AND TWISTING. THE CATHETER WAS REMOVED AND NOT USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849504 ↗
• MalfunctionJul 2, 2021Break; Break

  THE CATHETER WAS USED DURING AN IMPLANT PROCEDURE AND NO ALLEGATION WAS MADE AGAINST THE PRODUCT. THE CATHETER WAS RETURNED TO THE MANUFACTURER AND, SUBSEQUENTLY, TESTED OUT OF SPECIFICATION DURING THE PRODUCT ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12111070 ↗
• MalfunctionMar 24, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE HEMOSTATIC VALVE OF THE DELIVERY CATHETER ALLOWED FLUID TO SPRAY BACK AT THE OPERATOR DURING THE DYE INJECTION. THE CATHETER WAS REMOVED AND NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11562638 ↗
• MalfunctionJan 11, 2021Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS DAMAGED DURING THE IMPLANT PROCEDURE. IT WAS ADDITIONALLY NOTED THAT THE CATHETER WAS SUSPECTED TO HAVE FRACTURED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11149851 ↗
• MalfunctionDec 30, 2020Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DELIVERY CATHETER TORE. THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11095747 ↗
• MalfunctionDec 15, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING USE THE DELIVERY CATHETER COULD NOT BE CUT "NORMALLY". THE DELIVERY CATHETER WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DELIVERY CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11013761 ↗
• MalfunctionDec 11, 2020Accessory Incompatible; Break; Accessory Incompatible; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER AND TWO HIS BUNDLE LEADS WERE BROKEN. IT WAS NOTED THAT DURING THE FIRST INSERTION OF THE SHEATH AND THE HIS LEAD, THE PHYSICIAN TRIED LOCATING A TARGET SPOT, BUT THERE WAS NO GOOD HIS SIGNAL, THEREFORE THE PHYSICIAN DECIDED TO CHANGE THE LOCATION. THE PHYSICIAN REMOVED THE LEAD TO INSPECT THE HELIX AND REINSERTED BACK INTO THE CATHETER SHEATH AND FOUND SOME RESISTANCE DURING INSERTION. THE PHYSICIAN REMOVED THE SHEATH AND LEAD AND FOUND A ¿CUT LIKE TEAR ON THE SHEATH¿. THE CATHETER WAS REPLACED. THE PHYSICIAN ATTEMPTED TO SCREW IN THE HIS LEAD WITH MUCH RESISTANCE. THE PHYSICIAN TURNED THE LEAD MULTIPLE TIMES, BUT THE LEAD ¿DID NOT PROGRESS¿. THE PHYSICIAN REMOVED THE LEAD AND NOTICED THAT THE LEAD WAS BROKEN AT AN ANGLE. THE LEAD WAS REPLACED, AND A SIMILAR ¿FATE¿ OCCURRED WITH ANOTHER HIS BUNDLE LEAD. THE HIS BUNDLE LEAD WAS NOT USED, AND ANOTHER LEAD WAS IMPLANTED. THE NEWLY IMPLANTED LEAD HAD HIGH INITIAL IMPEDANCE AND THRESHOLD MEASUREMENTS BUT DROPPED DURING CLOSING OF THE POCKET. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10991877 ↗
• MalfunctionNov 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER SHEATH BROKE DUE TO A LONG PROCEDURE TIME. IT WAS NOTED THAT THE SHEATH WAS USED DUE TO THE PATIENT¿S MYOCARDIUM AND THE PHYSICIAN FOUND MANY SUITABLE POSITIONS, BUT THEY ALL WERE UNSUCCESSFUL. THE CATHETER WAS REPLACED WITH ANOTHER CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10905120 ↗
• MalfunctionOct 26, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING IMPLANT, THE CATHETER COULD NOT BE WITHDRAWN NORMALLY. THE CATHETER WAS REPLACED AND THE OPERATION WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10736515 ↗
• MalfunctionOct 23, 2020Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHEN PLACING THE LEFT VENTRICULAR (LV) LEAD. THE SHEATH WAS WITHDRAWN, AND THE PHYSICIAN NOTICED THE CATHETER WAS BROKEN AND IT ¿LOST ITS SUPPORT¿. THE CATHETER WAS NOT USED, AND ANOTHER CATHETER WAS USED FOR THE IMPLANT PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10726612 ↗
• MalfunctionOct 20, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WHEN PEELING THE SHEATH DURING THE IMPLANT PROCEDURE, THE CATHETER VALVE WAS NOT CUT CORRECTLY, CAUSING THE ELECTRODE TO ¿TANGLE¿ IN THE VALVE, RESULTING IN THE SHEATH BECOMING CLOSER TO THE DISTAL PART OF THE ELECTRODE. THE PHYSICIAN USED A MOSQUITO TOOL TO PEEL AND REMOVE THE VALVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10704122 ↗
• MalfunctionAug 11, 2020Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN THE PHYSICIAN INSERTED THE LEAD INTO THE CATHETER AND MOVED IT TO THE TARGET LOCATION, THE LEAD SEEMED TO GET STUCK. A KINK IN THE CATHETER WAS FOUND DURING FLUOROSCOPY AND THE CATHETER WAS REMOVED. UPON INSPECTION, A DEEP KINK WAS FOUND AND THE CATHETER BROKE. A NEW CATHETER WAS USED TO IMPLANT THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10390973 ↗
• MalfunctionAug 7, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, IT WAS DISCOVERED THE HEMOSTATIS VALVE ON THE CATHETER WAS TURNED TO THE SIDE AND A WIRE WAS UNABLE TO BE ADVANCED. THE PRODUCT WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10379624 ↗
• MalfunctionJul 6, 2020Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER SNAPPED DURING SLITTING. THE CATHETER WAS REMOVED AND A NEW ONE WAS USED WITHOUT ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10233783 ↗
• MalfunctionJun 26, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER SLITTING THE CATHETER, THE BLUE RUBBER ¿VALVE¿ WASN'T SLIT AND REMAINED AS A RING AROUND THE LEAD. THE LEAD WAS ULTIMATELY PLACED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10201743 ↗
• MalfunctionMay 13, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING IMPLANT, THE INNER DELIVERY CATHETER WAS BLOCKED BY FOREIGN OBJECTS WHICH PREVENTED THE GUIDEWIRE FROM ENTERING THE CATHETER. A DIFFERENT CATHETER WAS USED TO COMPLETE THE IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10053893 ↗
• MalfunctionApr 28, 2020Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, WHILE SLITTING THE CATHETER, THE LEAD DISLODGED. THE DIFFERENT CATHETER WAS USED, THE SAME LEAD WAS POSITIONED AGAIN AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10004428 ↗
• MalfunctionApr 20, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER ONLY WAS ASPIRATING AIR. THE CATHETER WAS CHECKED AND IT WAS DETERMINED THAT THE HEMOSTASIS VALVE WAS VERY LOOSE. THE CATHETER WAS REMOVED AND A SECOND CATHETER WAS ATTEMPTED. THE VALVE OF THE SECOND CATHETER WAS TIGHTER THAN THE PREVIOUS ONE, BUT IT STILL DID NOT SEAL WELL. THE SECOND CATHETERS WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9978868 ↗
• MalfunctionApr 20, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER ONLY WAS ASPIRATING AIR. THE CATHETER WAS CHECKED AND IT WAS DETERMINED THAT THE HEMOSTASIS VALVE WAS VERY LOOSE. THE CATHETER WAS REMOVED AND A SECOND CATHETER WAS ATTEMPTED. THE VALVE OF THE SECOND CATHETER WAS TIGHTER THAN THE PREVIOUS ONE, BUT IT STILL DID NOT SEAL WELL. THE SECOND CATHETERS WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9978857 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANT, THE PATIENT SUFFERED SUDDEN HEART FAILURE. THE OPERATION WAS SUSPENDED AND THE PATIENT WAS GIVEN OXYGEN, ALONG WITH INTRAVENOUS MEDICATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Failure

  MAUDE report 9940533 ↗
• MalfunctionMar 18, 2020Accessory Incompatible; Break; Accessory Incompatible; Break

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE LEAD COULD NOT PASS THROUGH THE DELIVERY CATHETER. IT WAS NOTED THAT THE CATHETER HAD A TEAR AT THE PROXIMAL END, CAUSING THE LEAD TO BE STUCK. THE CATHETER WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9850155 ↗
• MalfunctionMar 12, 2020Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER VALVE WAS DISLODGED WHEN THE DILATOR WAS PULLED OUT. THE CATHETER WAS REMOVED AND A NEW CATHETER WAS USED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9825476 ↗
• MalfunctionMar 11, 2020Accessory Incompatible; Break; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Material Split, Cut or Torn; Accessory Incompatible; Break; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD. THE HELIX WAS UNABLE TO MOVE INSIDE THE CATHETER ANYMORE. THE LEAD WAS REMOVED AND REPLACED. IT WAS NOTICED THAT THE CATHETER WAS DAMAGED WITH A SLIT AND KINK. THE CATHETER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9819839 ↗
• MalfunctionMar 6, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING SLITTING, THE VALVE OF THE DELIVERY CATHETER WOULD NOT SLIT, RATHER IT WAS PUSHED OUT AND HAD TO BE CUT WITH A SCISSOR. THE DELIVERY CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9799238 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE INVOLVING A PACING LEAD AND DELIVERY CATHETER, THE PATIENT SUDDENLY LOST CONSCIOUSNESS, HAD DIFFICULTY BREATHING AND COULD NOT LIE FLAT. THE PRODUCTS WERE REMOVED AND THE LEAD WAS NOT IMPLANTED. THE PATIENT REQUIRED ENDOTRACHEAL INTUBATION AND RESCUE. AFTER THAT, THE PATIENT WAS STABLE WITH NORMAL VITAL SIGNS. THE PATIENT WAS RETURNED TO THE WARD FOR MONITORING AND WILL WAIT FOR ELECTIVE SURGERY AT A LATER TIME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Syncope

  MAUDE report 9792831 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101885. One submission often covers many models, so check the product and lot details in each record.

• Z-0173-2022 · Sep 9, 2021 · Open, Classified
  C315-HIS Delivery Catheter