ARROW IPN915322Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10801902161946), received between Sep 30, 2022 and Apr 12, 2024 — classified as 7 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

26 other recalls cover devices cleared under the same FDA submission (K000729); 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.

Recalls naming this device

1. Apr 29, 2024Open, Classified

   Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

   Z-1879-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2024

  APPROXIMATELY 16 HOURS AFTER INSERTION OF AN IAPB (INTRA-AORTIC BALLOON PUMP) IN THE CATH LAB, THE BALLOON MEMBRANE RUPTURED, AND BLOOD BEGAN TO FLOW INTO THE HELIUM DRIVE LINE. THE LINE WAS CLAMPED, THE PUMP WAS STOPPED. PATIENT WAS TAKEN TO THE CATH LAB TO RECEIVE A REPLACEMENT IABP, SECOND DEVICE WAS INSERTED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095413 ↗
• MalfunctionAug 2, 2023Gas/Air Leak; Gas/Air Leak

  THE REPORT STATES, "IAB INSERTED UNDER FLUOROSCOPY PRIOR INTERVENTIONAL CARDIAC PROCEDURE, ON COMMENCEMENT OF IABP THERAPY USING A GENTINGE DEVICE, NOTED BLOOD IN THE DRIVE LINE, THERAPY CEASED AND IAB REMOVED". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17444366 ↗
• MalfunctionAug 2, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE USER ATTEMPTED TO INSERT THE IAB BUT THE IAB "BALLOON COULD NOT BE ENTERED INTO, AND HE TRIED TO PUMP BACK THE AIR INSIDE THE BALLOON, BUT IT STILL COULD NOT BE ENTERED INTO, AND HE TRIED TO RETREAT THE SHEATH, BUT IT COULD NOT BE WITHDRAWN, AND HE TRY FOR 10 MINUTES BUT COULD NOT BE SUCCESSFUL, AND THE DIRECTOR DECIDED TO GIVE UP". AS A RESULT, THE IAB WAS REMOVED. IT WAS FOUND THAT THE BALLOON WAS STUCK TO THE SHEATH. ANOTHER IAB WAS NOT INSERTED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17440008 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS "IAB RUPTURE". WHILE IN USE ON A PATIENT, BLOOD WAS NOTED IN THE GAS TUBING. AS A RESULT, THE IAB WAS REMOVED. ANOTHER IAB WAS NOT INSERTED AS THE PATIENT WAS STABLE AND IABP THERAPY WAS DISCONTINUED. NO PATIENT HARM OR INJURY. PATIENT STATUS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17231950 ↗
• MalfunctionJun 19, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "AFTER 3 MINUTES OF USE, THE MACHINE FREQUENTLY ALARMS 'HELIUM LEAKAGE'. ADJUSTING THE EQUIPMENT AND CATHETER CANNOT SOLVE THE PROBLEM. AFTER REPLACING THE CATHETER, THE PROBLEM WAS RESOLVED. IN VITRO EXPERIMENTS CONFIRMED THAT THE TIP OF THE CATHETER WAS DAMAGED AND HELIUM LEAKAGE OCCURRED.". THE 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17152142 ↗
• MalfunctionApr 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD WAS NOTED IN THE DRIVELINE TUBING, THE IAB HAD RUPTURED. AS A RESULT, THE IAB WAS REMOVED. AT THE TIME OF THIS REPORT, THE PATIENT IS ON THE OR SCHEDULE FOR REPLACEMENT OF IAB. NO PATIENT HARM OR INJURY. PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827825 ↗
• MalfunctionMar 16, 2023Defective Device; Defective Device

  REPORTED AS "STERILE COVERING ISSUE". IT WAS REPORTED THAT THE SHEATH PROTECTOR CAME OFF OF THE WINGED SUTURE POINT OR FROM THE BLUE HUB OF THE SHEATH. THIS IS AN AXILLARY INSERTION. ONCE THE SHEATH PROTECTOR CAME OFF, IT EXPOSED THE CATHETER AND THEY HAD TO TAKE THE PATIENT BACK TO THE CATH LAB TO REPLACE THE CATHETER. THE PUMP WAS PUMPING WITHOUT ALARMS, THE BALLOON WAS FUNCTIONING. THIS WAS JUST BECAUSE THE SHEATH PROTECTOR CAME OFF OF THE CONNECTION. THEY ALSO STATED THAT THE SHEATH PROTECTOR WAS NOT STRETCHED OUT TIGHT THERE WAS SOME BUNCHING OF THE SHEATH PROTECTOR COVERING. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH. PATIENT STATUS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16555143 ↗
• MalfunctionMar 16, 2023Defective Device; Defective Device

  REPORTED AS "STERILE COVERING ISSUE". IT WAS REPORTED THAT THE SHEATH PROTECTOR CAME OFF OF THE WINGED SUTURE POINT OR FROM THE BLUE HUB OF THE SHEATH. THIS IS AN AXILLARY INSERTION. ONCE THE SHEATH PROTECTOR CAME OFF, IT EXPOSED THE CATHETER AND THEY HAD TO TAKE THE PATIENT BACK TO THE CATH LAB TO REPLACE THE CATHETER. THE PUMP WAS PUMPING WITHOUT ALARMS, THE BALLOON WAS FUNCTIONING. THIS WAS JUST BECAUSE THE SHEATH PROTECTOR CAME OFF OF THE CONNECTION. THEY ALSO STATED THAT THE SHEATH PROTECTOR WAS NOT STRETCHED OUT TIGHT THERE WAS SOME BUNCHING OF THE SHEATH PROTECTOR COVERING. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH. PATIENT STATUS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16555123 ↗
• InjuryMar 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE IAB WAS INSERTED INTO THE RIGHT FEMORAL ARTERY ON THE MORNING OF (B)(6) 2023. THAT EVENING, THE IABP ALARMED AND BLOOD WAS FOUND IN THE IAB HELIUM TUBE. THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT A DIFFERENT INSERTION SITE AT THE LEFT FEMORAL ARTERY. INSPECTION OF THE DAMAGED CATHETER REVEALED THAT THE CENTRAL CAVITY WAS FOUND TO BE BROKEN. THE PATIENT STATUS IS REPORTED AS "CRITICAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554170 ↗
• MalfunctionMar 9, 2023Defective Device; Defective Device

  REPORTED AS "STERILE COVERING ISSUE". IT WAS REPORTED THAT THE SHEATH PROTECTOR CAME OFF OF THE WINGED SUTURE POINT OR FROM THE BLUE HUB OF THE SHEATH. IT IS AN AXILLARY INSERTION. ONCE THE SHEATH PROTECTOR CAME OFF, IT EXPOSED THE CATHETER AND THEY HAD TO TAKE THE PATIENT BACK TO THE CATH LAB TO REPLACE THE CATHETER. THE PUMP WAS PUMPING WITHOUT ALARMS, THE BALLOON WAS FUNCTIONING. THIS WAS BECAUSE THE SHEATH PROTECTOR CAME OFF OF THE CONNECTION. THE CUSTOMER ALSO STATED THAT THE SHEATH PROTECTOR WAS NOT STRETCHED OUT TIGHT, THERE WAS SOME BUNCHING OF THE SHEATH PROTECTOR COVERING. THE SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518600 ↗
• MalfunctionFeb 22, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT "IN THE ENDOCARDIAL CATHETERIZATION LABORATORY OF (B)(6) HOSPITAL, IABP WAS INSERTED TO ASSIST CARDIAC FUNCTION AFTER CAG+PTCA. THE OPERATOR INSERTED THE BALLOON ALONG THE SHEATH, BUT IT COULD NOT BE FULLY INSERTED. THE OPERATOR MOVED THE BALLOON POSITION SLIGHTLY, BUT IT STILL COULD NOT BE INSERTED. THE OPERATOR WITHDREW THE BALLOON, A ONE-WAY VALVE WAS CONNECTED, BUT IT STILL COULD NOT BE INSERTED COMPLETELY. AFTER WITHDRAWING THE BALLOON, IT WAS REPLACED WITH A NEW CATHETER; IT IS NORMAL". THE 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418720 ↗
• MalfunctionFeb 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "AT ABOUT 14:00 ON (B)(6) 2023, IN THE CARDIAC SURGERY WARD, AFTER THE CATHETER WAS INSERTED INTO THE BODY, THE MACHINE GAVE AN ALARM AND THE BALLOON RUPTURE AFTER ONE DAY OF USE." THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH. THE 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16410276 ↗
• MalfunctionFeb 21, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT ON "(B)(6) 2022, THE PATIENT UNDERWENT EMERGENCY PCI UNDER DSA. AFTER THE OPERATION, THE BLOOD PRESSURE DROPPED. THE IABP CATHETER WAS INSERTED THROUGH THE RIGHT FEMORAL ARTERY, AND THE IABP WAS STARTED. THE MACHINE STOPPED WORKING FOR SEVERAL CARDIAC CYCLES AND GAVE AN ALARM. UNDER DSA, IT WAS FOUND THAT THE BALLOON COULD NOT INFLATE NORMALLY. AFTER REPLACING THE NEW CATHETER, THE MACHINE WORKED NORMALLY AND THE PATIENT WAS TRANSFERRED TO THE WARD SMOOTHLY". THE 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409968 ↗
• InjuryFeb 21, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE, "MET WITH PHYSICIAN TO EXPLAIN THREE DIFFERENT ISSUES THEY HAD WITH OUR BALLOONS. THEY PLACED BALLOONS VIA FEMORAL AND EXPERIENCED EMBOLIC EVENTS. IN SPECIFIC, THEY HAD ISSUES WITH THE LIVER, SPLEEN, MESENTERIC ARTERIALS (BOWELS) AND RENAL. I WAS TOLD THE THREE PATIENTS ALL OCCURRED WITHIN THE LAST 6 MONTHS". ALTHOUGH LIMITED INFORMATION WAS ABLE TO BE OBTAINED ABOUT THIS PATIENT, OUT OF AN ABUNDANCE OF CAUTION, TELEFLEX HAS MADE THIS EVENT REPORTABLE BASED ON THE TWO PRIOR COMPLAINTS RECEIVED FROM THE SAME FACILITY, ON THE SAME PRODUCT WITH SIMILAR PATIENT OUTCOMES. THE THREE TOTAL COMPLAINTS WERE RECEIVED AT THE SAME TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Embolism/Embolus

  MAUDE report 16408322 ↗
• InjuryFeb 21, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THERE WERE THREE DIFFERENT EVENTS ON THREE DIFFERENT PATIENTS IN THE LAST SIX MONTHS. THE REPORT STATES, "ON 8/3/22, SHE PRESENTED TO TMC WITH SUBACUTE WORSENING DYSPNEA ON EXERTION AND WAS FOUND TO BE IN ACUTE ON CHRONIC HFREF WHICH PROGRESSED TO CARDIOGENIC SHOCK. ON (B)(6) 2022, AN ULTRA FLEX 7F 40CC IABP WAS PLACED FEMORALLY. THE PATIENT WAS ANTICOAGULATED WITH HEPARIN GTT WITH THERAPEUTIC ANTI-XA AND WAS KEPT ON 1:1 IABP. ON 8/22/22, SHE DEVELOPED ACUTE LIMB ISCHEMIA OF BOTH FEET DUE TO THROMBOEMBOLI THOUGHT TO BE COMING FROM THE IABP. SHE WAS ALSO FOUND TO HAVE MULTIPLE SPLENIC INFARCTS AND BILATERAL RENAL INFARCTS. SHE ALSO HAD SEVERE TRANSIENT HEPATIC FAILURE RIGHT AFTER IABP WHICH RETROSPECTIVELY MIGHT HAVE BEEN RELATED TO EMBOLIC PHENOMENON TO THE LIVER. IABP REMOVED AND SHE WAS PLACED ON VA ECMO. UNFORTUNATELY, HER COURSE WAS COMPLICATED BY SEVERE GASTROINTESTINAL BLEEDING AND GALLBLADDER PERFORATION MAKING HER NOT A SURGICAL CANDIDATE FOR BIVENTRICULAR ASSIST DEVICE SURGERY. THE PATIENT WAS TRANSITIONED TO COMFORT MEASURES ONLY. ON (B)(6) 2022, THE PATIENT EXPIRED.".

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cardiogenic Shock; Dyspnea; Hemorrhage/Blood Loss/Bleeding; Ischemia; Perforation; Unspecified Hepatic or Biliary Problem

  MAUDE report 16407898 ↗
• InjuryFeb 21, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THERE WERE THREE DIFFERENT EVENTS ON THREE DIFFERENT PATIENTS IN THE LAST SIX MONTHS. THE REPORT STATES, "IN OC TOBER 2022 THE PATIENT HAD A VENTRICULAR TACHYCARDIA (VT) ARREST, CARDIOGENIC SHOCK, AND WAS LISTED FOR HEART TRANSPLANT. ADMITTED ON (B)(6)22 FOR ADVANCED THERAPIES AND VAD/TRANSPLANT EVALUATION. ON (B)(6)22, AN ULTRA FLEX 7F 40 CC IABP PLACED IN THE RIGHT FEMORAL ARTERY FOR WORSENING CARDIOGENIC SHOCK. THE PATIENT WAS HEPARINIZED WITH THERAPEUTIC ANTI-XA AND THE PATIENT WAS ON 1:1 IABP. LATER THAT DAY, THE PATIENT DEVELOPED ABDOMINAL PAIN, WHICH WAS FOUND ON CTA TO BE SECONDARY TO ARTERIAL THROMBI IN THE RIGHT HEPATIC ARTERY AND ITS PROXIMAL BRANCHES AND IN SEGMENTAL BRANCHES OF THE LEFT KIDNEY, WITH MULTIPLE RENAL INFARCTS. ON (B)(6)22, THE IABP WAS DISCONTINUED DUE TO THROMBOTIC/EMBOLIC COMPLICATIONS - IABP-RELATED ARTERIAL EMBOLISM. HE ALSO DEVELOPED LOSS OF DISTAL PULSES IN THE RIGHT LOWER EXTREMITY REQUIRING SURGERY AS BELOW. HEPARIN INDUCED THROMBOCYTOPENIA WAS THOUGHT TO BE UNLIKELY AFTER CLINICAL AND LABORATORY ASSESSMENT. THE PATIENT WAS ANTICOAGULATED WITH BIVALRUDIN. HE HAD WORSENING ACUTE KIDNEY INJURY ON CHRONIC KIDNEY INJURY. ANOTHER B

  Patient problems: Abdominal Pain; Cardiac Arrest; Cardiogenic Shock; Diminished Pulse Pressure; Failure of Implant; Tachycardia; Thromboembolism; Unspecified Kidney or Urinary Problem

  MAUDE report 16407741 ↗
• MalfunctionFeb 2, 2023Leak/Splash; Leak/Splash

  THE REPORT STATES "POSSIBLE IAB ABRASION. AS A RESULT, IAB WAS REMOVED AND DISPOSED. THERAPY DISCONTINUED. NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH". PATIENT STATUS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16284635 ↗
• InjuryJan 13, 2023Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT "ON NOVEMBER 25, 2022, (B)(6) COULD NOT PULL OUT THE IABP CATHETER WHEN REMOVING IT AFTER IABP INSERTION. IN THE PROCESS OF USE, IT WAS FOUND THAT THERE WAS BLOOD IN THE HELIUM CATHETER, AND THE LEFT FEMORAL ARTERY WAS CUT SURGICALLY TO TAKE IT OUT. " ADDITIONAL INFORMATION STATES THAT A SECOND CATHETER WAS INSERTED IN THE RIGHT FEMORAL ARTERY AFTER REMOVAL OF THE IAB. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157330 ↗
• InjuryJan 12, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DAY AFTER THE CATHETER WAS INSERTED, THE PUMP ALARMED, AND THE NURSE FOUND THE THAT THE CONNECTION BETWEEN THE SHEATH HUB AND THE SUTURE WING WAS LOOSE. THE CATHETER WAS REMOVED, AND A SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16151254 ↗
• MalfunctionJan 12, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DAY AFTER THE CATHETER WAS INSERTED, THE PUMP ALARMED, AND THE NURSE FOUND THE THAT THE CONNECTION BETWEEN THE SHEATH HUB AND THE SUTURE WING WAS LOOSE. THE CATHETER WAS REMOVED, AND A SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16150854 ↗
• MalfunctionJan 12, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "IN THE OPERATING ROOM OF (B)(6) HOSPITAL, THE BALLOON INFLATED AFTER INSERTION. DURING THE WORKING, THE MACHINE ALARM AIR LEAKAGE. AFTER REMOVAL THE CATHETER, THE BALLOON WAS FOUND RUPTURED." ADDITIONAL INFORMATION STATES A SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO MEDICAL INTERVENTION NECESSARY. NO REPORT OF PATIENT HARM OR INJURY. PATIENT STATUS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16148776 ↗
• MalfunctionJan 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER PLACEMENT OF THE CATHETER THE PATIENT WAS TRANSFERRED TO THE ICU. THE NEXT DAY, BLOOD WAS FOUND IN THE HELIUM TUBE. THE CATHETER WAS REMOVED. THE CATHETER WAS NOT REPLACED. A DIFFERENT THERAPY WAS INITIATED ON THE PATIENT. NO REPORT OF PATIENT INJURY OR HARM. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16122439 ↗
• MalfunctionJan 9, 2023Leak/Splash; Leak/Splash

  IT IS REPORTED THAT AFTER THE CATHETER WAS INSERTED, THE BALLOON WAS FOUND TO BE RUPTURED. A SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO MEDICAL INTERVENTION NECESSARY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16122267 ↗
• MalfunctionDec 20, 2022Inflation Problem; Inflation Problem

  THE REPORT STATES THAT THE BALLOON WOULD ONLY PARTIALLY INFLATE WHEN INSERTED WHILE IN USE ON A PATIENT. AS A RESULT, ANOTHER IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT INJURY OR CONSEQUENCE. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016499 ↗
• MalfunctionDec 20, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE ALLEGED 40CC IAB CATHETER CONNECTED TO A CARDIOSAVE IABP HAD BEEN PUT IN THE PATIENT SINCE 15 NOV. AN ALARM OF GAS LOSS IN IAB CIRCUIT FIRST APPEARED ON 24 NOV, BUT NO BLOOD WAS FOUND IN THE HELIUM TUBING AND DIFFERENT ALARMS WERE ACTIVATED SINCE THEN. THE USER REPORTED NO KINKING OF THE CATHETER. TO RETRIEVE THE ALARM HISTORY, THE USER CHANGED THE CONNECTION OF THE ALLEGED CATHETER TO ANOTHER CARDIOSAVE IABP UNIT ON 25 NOV AND GAS LOSS ALARM STILL APPEARED. ON 26 NOV, THE PHYSICIAN WITHDREW THE ALLEGED IAB CATHETER WITH THE SHEATH AS A WHOLE AND EXCHANGED FOR A NEW IAB CATHETER FOR THE PATIENT TO CONTINUE THE IABP CIRCULATORY SUPPORT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014487 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000729. One submission often covers many models, so check the product and lot details in each record.

• Z-1880-2024 · Apr 29, 2024 · Open, Classified
  Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
• Z-1059-2016 · Feb 10, 2016 · Terminated
  UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during di
• Z-1056-2016 · Feb 10, 2016 · Terminated
  Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diasto
• Z-1060-2016 · Feb 10, 2016 · Terminated
  UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during di
• Z-1058-2016 · Feb 10, 2016 · Terminated
  Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diasto
• Z-1062-2016 · Feb 10, 2016 · Terminated
  Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during di
• Z-1064-2013 · Nov 27, 2012 · Terminated
  Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation t
• Z-1065-2013 · Nov 27, 2012 · Terminated
  Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation th
• Z-0969-2011 · Oct 11, 2010 · Terminated
  Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
• Z-0791-2011 · Oct 11, 2010 · Terminated
  Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U
• Z-0793-2011 · Oct 11, 2010 · Terminated
  FiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-LWS
• Z-0790-2011 · Oct 11, 2010 · Terminated
  Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U
• Z-0792-2011 · Oct 11, 2010 · Terminated
  FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS
• Z-1214-2009 · Feb 2, 2009 · Terminated
  7.5 Fr 30cc UltraFlex IAB, IAB-06830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in
• Z-1220-2009 · Feb 2, 2009 · Terminated
  9 FR 50CC Rediguard IAB, IAB-R950-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the

…and 11 more.