Arctic Front Advance™ 2AF284 (UDI 00643169753693)Recalls & reported problems

Summary

The FDA's MAUDE database contains 144 adverse event reports that list this exact device (DI 00643169753693), received between Dec 28, 2016 and Apr 22, 2019 — classified as 9 deaths, 61 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Kinked” (21 reports).

1 other recall cover devices cleared under the same FDA submission (P100010); 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 144 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  AFTER A COMPLETED CASE, THE BALLOON CATHETER SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8536433 ↗
• InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NINE MONTHS POST CRYO ABLATION PROCEDURE, THE PATIENT HAD SEVERE STENOSIS IN THE LEFT SUPERIOR PULMONARY VEIN (LSPV) AND RIGHT SUPERIOR PULMONARY VEIN (RSPV) AS NOTED VIA COMPUTED TOMOGRAPHY (CT) SCAN. THE PATIENT IS ASYMPTOMATIC, AND THERE WAS NO MEDICAL INTERVENTION AND EXTENDED HOSPITALIZATION NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION INDICATED THAT THE PV STENOSIS HAD WORSENED, REQUIRING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TO BE SCHEDULED. FURTHERMORE, IT WAS REPORTED THAT THE STENOSIS OCCURRED DUE TO NEOINTIMAL PROLIFERATION AND THERE WAS SOME INJURY BROUGHT TO THE VESSEL WALL.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 8418367 ↗
• MalfunctionMar 1, 2019Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  AFTER A CASE WAS COMPLETED WITH CRYO, THE BALLOON CATHETER AND MAPPING CATHETER SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8383602 ↗
• MalfunctionJan 31, 2019Material Integrity Problem; Material Integrity Problem

  THE BALLOON CATHETER TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8292971 ↗
• InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMMEDIATELY POST COMPLETION OF A CRYO ABLATION PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN, AND A SLIGHT PERICARDIAL EFFUSION WAS OBSERVED. THE PATIENT'S HOSPITALIZATION WAS EXTENDED AND THEIR CONDITION WAS MONITORED. THE PATIENT WAS SUBSEQUENTLY DISCHARGED FROM THE HOSPITAL. IT WAS NOTED THAT THE ABLATION WAS NOT PERFORMED SUFFICIENTLY ACCORDING TO THE MANNER IN WHICH THE TEMPERATURE DECREASED AND PER FLUOROSCOPY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Pericardial Effusion

  MAUDE report 8291118 ↗
• MalfunctionJan 15, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE BALLOON CATHETER SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8249949 ↗
• MalfunctionDec 17, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON SHAPE WAS NOT AS EXPECTED AS THE SHAFT WAS NOT IN THE CENTER OF THE BALLOON. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE BALLOON CATHETER SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8168050 ↗
• MalfunctionNov 30, 2018Material Twisted/Bent; Material Twisted/Bent

  AFTER A COMPLETED CASE, THE BALLOON CATHETER WAS RETURNED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVEST IGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8118838 ↗
• MalfunctionNov 15, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON LOOKED BENT AND THE "STEERING MECHANISM AND DEFLECTION WAS BROKE". THE BALLOON CATHETER WAS REPLACED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE BALLOON CATHETER SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8075764 ↗
• MalfunctionNov 8, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON CATHETER LOOK KINKED. ADDITIONALLY, THERE WAS DIFFICULTY ISOLATING THE LEFT INFERIOR PULMONARY VEIN (LIPV), AND ISSUE WITH MANIPULATING THE CATHETER. THE CASE WAS SWITCHED TO AND COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE BALLOON CATHETER SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8054081 ↗
• MalfunctionNov 6, 2018Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AFTER BALLOON CATHETER SET UP, AIR ASPIRATION WAS UNSUCCESSFUL AS AIR WAS INTRODUCED CONTINUOUSLY. THE SHEATH WAS REPLACED WITHOUT RESOLVE. FINALLY, THE BALLOON CATHETER WAS REPLACED TO RESOLVE THE AIR INGRESS ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8043685 ↗
• MalfunctionNov 6, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON CATHETER SHAFT WAS FOUND TO HAVE A KINK, BELOW THE BALLOON. THE BALLOON CATHETER WAS REPLACED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE BALLOON CATHETER WAS RETURNED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8042732 ↗
• MalfunctionOct 25, 2018Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE FLOW AND PRESSURE WERE NOT AS EXPECTED. IT WAS ALSO REPORTED THAT THE TEMPERATURE DID NOT DECREASE ENOUGH. THE COAXIAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLVE. THE BALLOON CATHETER WAS THEN REPLACED AND THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE BALLOON CATHETER SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8005451 ↗
• MalfunctionOct 23, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER A CRYO ABLATION SELF TEST, THE BALLOON CATHETER TEMPERATURES WERE NOT AS EXPECTED. IT WAS ALSO REPORTED THAT THE BALLOON CATHETER AND SHEATH HAD AN "ABNORMALLY TIGHT FIT." THE BALLOON CATHETER WAS REPLACED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE BALLOON CATHETER SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7997321 ↗
• MalfunctionOct 18, 2018Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE BALLOON CATHETER WAS REPLACED WITHOUT ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE BALLOON CATHETER WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7981759 ↗
• MalfunctionOct 9, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE SHAFT OF THE BALLOON CATHETER WAS BENT. THE BALLOON CATHETER WAS REPLACED AND THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE CATHETER WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7948522 ↗
• MalfunctionOct 4, 2018Break; Break

  THE BALLOON CATHETER WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7935723 ↗
• InjuryOct 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY POST CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED ATYPICAL CHEST PAIN, AND ALSO WAS DIAGNOSED WITH GASTROESOPHAGEAL REFLUX DISEASE (GERD). ADDITIONALLY, THE PATIENT HAD COMPLAINTS OF NECK PAIN, DIFFICULTY SWALLOWING AND COUGHING BOUTS. IT WAS ALSO REPORTED THAT THE PATIENT HAD HYPOTENSION. THE CASE WAS ALREADY COMPLETED WITH CRYO. THE PATIENT WAS SUBSEQUENTLY STARTED ON AN ANTI-INFLAMMATORY WITH A PROTON PUMP INHIBITOR, AND A MODIFICATION TO HIS CURRENT MEDICATION REGIMEN WAS PERFORMED. THE PATIENT HAD AN EXTENDED HOSPITALIZATION. THE PATIENT'S SYMPTOMS THEN RESOLVED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS PART OF THE (B)(6) CLINICAL STUDY.

  Patient problems: Chest Pain; Discomfort; Dysphagia/ Odynophagia; Low Blood Pressure/ Hypotension; Neck Pain; No Code Available

  MAUDE report 7923186 ↗
• MalfunctionSep 24, 2018Break; Break

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, MULTIPLE SYSTEM NOTICES WERE RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. THE BALLOON CATHETER WAS REPLACED BUT THE SYSTEM NOTICE PERSISTED. THE CASE WAS COMPLETED WITH CRYO. A SERVICE VISIT TOOK PLACE AND THE CONSOLE WAS SERVICED AS APPROPRIATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE BALLOON CATHETER WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7903662 ↗
• MalfunctionSep 24, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHEN THE BALLOON CATHETER WAS INSERTED INTO THE SHEATH, RESISTANCE WAS SLIGHTLY EXPERIENCED. THE BALLOON CATHETER SHAFT WAS FOUND BENT, THE PUSH BUTTON WAS PRESSED WITHOUT RESOLVE. THEN, THE BALLOON CATHETER WAS REPLACED WITH RESOLUTION. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE BALLOON CATHETER WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7902500 ↗
• MalfunctionSep 18, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHILE INFLATING THE BALLOON CATHETER OUTSIDE OF THE BODY, A KINK WAS OBSERVED ON THE SHAFT OF THE CATHETER. IT WAS NOTED THAT THIS OCCURRED IMMEDIATELY UPON TAKING THE CATHETER OUT OF THE PACKAGING. THE CATHETER WAS REPLACED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE BALLOON CATHETER WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7885949 ↗
• InjurySep 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, DURING ABLATION OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV), PHRENIC CAPTURE LOSS WAS OBSERVED. THE PHRENIC CAPTURE DID NOT RETURN, AND THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHRENIC NERVE PALSY HAS NOT RESOLVED/RECOVERED.

  Patient problems: Nerve Damage

  MAUDE report 7885425 ↗
• MalfunctionSep 14, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE COAXIAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLVE. THE ELECTRICAL CABLE AND AUTO CONNECTION BOX WERE ALSO REPLACED. A FREEZE WAS SUCCESSFUL, HOWEVER, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. THE BALLOON CATHETER WAS THEN REPLACED WHICH RESOLVED THE ISSUES. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE BALLOON CATHETER WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7878788 ↗
• MalfunctionSep 14, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE GUIDE WIRE LUMEN WAS KINKED ON THE BALLOON CATHETER. THE BALLOON CATHETER WAS REPLACED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7878378 ↗
• MalfunctionSep 12, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, DURING SETUP WHILE THE BALLOON CATHETER PUSH BUTTON WAS MANEUVERED, AND THE SHAFT WAS KINKED. THE BALLOON CATHETER WAS REPLACED. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE BALLOON CATHETER SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7868641 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100010. One submission often covers many models, so check the product and lot details in each record.

• Z-0149-2012 · Aug 29, 2011 · Terminated
  Medtronic Arctic Front Catheter, Sterile EO, Medtronic CryoCath LP, Kirkland, Quebec, H9H 5 H3, Canada, Model 2AF282 and 2AF231 ( not distributed in US) Product Usage: The Medtr