Arctic Front Advance Pro™ AFAPRO28 (UDI 00763000088637)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00763000088637), received between May 13, 2019 and Aug 31, 2020 — classified as 6 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (17 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2020Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10473329 ↗
• MalfunctionJul 22, 2020Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10308164 ↗
• MalfunctionJul 2, 2020Material Twisted/Bent; Material Twisted/Bent

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224677 ↗
• MalfunctionMay 7, 2020Material Twisted/Bent; Material Twisted/Bent

  AFTER A SUCCESSFUL CRYO ABLATION PROCEDURE, THE BALLOON CATHETER AND SHEATH SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10036906 ↗
• MalfunctionMay 6, 2020Material Integrity Problem; Material Integrity Problem

  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 10030537 ↗
• MalfunctionMay 6, 2020Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10029476 ↗
• MalfunctionApr 28, 2020Material Integrity Problem; Protective Measures Problem; Material Integrity Problem; Protective Measures Problem

  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 10006291 ↗
• MalfunctionApr 22, 2020Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AIR INGRESS OCCURRED WHEN THE BALLOON CATHETER WAS INSERTED INTO THE SHEATH. 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 9988315 ↗
• MalfunctionApr 17, 2020Material Twisted/Bent; 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 9974304 ↗
• MalfunctionMar 25, 2020Material Integrity Problem; Material Integrity Problem

  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 9880105 ↗
• MalfunctionMar 23, 2020Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; 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 9869761 ↗
• MalfunctionMar 13, 2020Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER WAS UNABLE TO PASS THROUGH THE BALLOON CATHETER AND RESISTANCE WAS FELT. A KINK WAS OBSERVED IN THE BALLOON CATHETER. THE BALLOON CATHETER WAS REPLACED. 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 9830058 ↗
• MalfunctionMar 4, 2020Material Integrity Problem; Material Integrity Problem

  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 9788796 ↗
• MalfunctionFeb 11, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE GUIDEWIRE LUMEN KINKED WHEN THE BALLOON CATHETER WAS INFLATED. THE BALLOON CATHETER WAS REPLACED. 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 9694516 ↗
• InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, SEVERAL ATTEMPTS WERE MADE TO CROSS THE SEPTUM DURING THE TRANSSEPTAL PUNCTURE. THE CASE WAS CONTINUED WITH CRYO. ON THE LAST FREEZE, THE PATIENT'S BLOOD PRESSURE DROPPED AND AN EFFUSION WAS OBSERVED ON ICE WITH A TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT'S HOSPITALIZATION STAY WAS EXTENDED. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 9679699 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCE PHRENIC NERVE PALSY (PNP). AT THE END OF THE PROCEDURE, THE PNP HAD NOT RECOVERED. THE CASE WAS COMPLETED WITH CRYO. THE PATIENT WAS WITHOUT SYMPTOMS PRIOR TO DISCHARGE, HOWEVER IT WAS NOT CLEAR IF THE PNP HAD RECOVERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 9586384 ↗
• MalfunctionDec 26, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON CATHETER SHAFT APPEARED TO BE DISPLACED FROM ITS 'NORMAL' MID-LINE POSITION IN THE BALLOON WHILE THE BALLOON WAS INFLATED. 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 9520852 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, BLOOD WAS OBSERVED IN THE ENDOTRACHEAL TUBE. THE LUNGS WERE SCOPED AND NO ACTIVE BLEEDING WAS OBSERVED. THE BLOOD WAS SUCTIONED OUT. ON THE NEXT OCCLUSION, BLOOD WAS AGAIN OBSERVED IN THE ET TUBE. THE PROCEDURE WAS STOPPED AND ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR HOSPITALIZATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 9453583 ↗
• MalfunctionNov 25, 2019Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; 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 9371364 ↗
• MalfunctionNov 20, 2019Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. THE BALLOON CATHETER WAS REPLACED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. THEN, WHEN PERFORMING TEST ABLATIONS, AIR BUBBLES WERE NOTED COMING FROM THE SURFACE OF THE BALLOON OF THE SECOND BALLOON CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9348938 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED PHRENIC NERVE PALSY (PNP). THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 9321579 ↗
• MalfunctionNov 13, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A KINK WAS NOTED TO THE BALLOON OF THE BALLOON CATHETER. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9315659 ↗
• MalfunctionNov 7, 2019Material Twisted/Bent; 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 9293452 ↗
• MalfunctionNov 5, 2019Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  AFTER A COMPLETED CASE, 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 9279227 ↗
• InjuryOct 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT HAD A DROP IN BLOOD PRESSURE DESPITE MEDICATION SUPPORT. AN ECHOCARDIOGRAM NOTED A PERICARDIAL EFFUSION AND A CARDIAC TAMPONADE WAS DIAGNOSED. A PERICARDIOCENTESIS WAS PERFORMED. THE CASE WAS COMPLETED WITH CRYO. THE PATIENT'S HOSPITAL STAY WAS EXTENDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 9215296 ↗

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