IN.PACT AdmiralRecalls & reported problems across all models

We found 39 models of IN.PACT Admiral by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 196 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2017 and May 15, 2026 — classified as 8 deaths, 108 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (41 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

IN.PACT Admiral recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 23, 2022Open, Classified

   Packaging for Balloon Catheters may be damaged resulting in loss of sterility.

   Z-1042-2022 · Root cause: Packaging process control · names 17 of these models · Recall details · FDA record ↗

Most reported IN.PACT Admiral problems

IN.PACT Admiral models

39 models, most reported first. Each model has its own page with its reports, recalls and device details.

• IN.PACT™ Admiral™ ADM06004013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall12 reports
• IN.PACT™ Admiral™ ADM06015013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall11 reports
• IN.PACT™ Admiral™ ADM04015013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall8 reports
• IN.PACT™ Admiral™ ADM06006013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall1 death7 reports
• IN.PACT™ Admiral™ ADM06008013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall7 reports
• IN.PACT™ Admiral™ ADM04012013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall1 death7 reports
• IN.PACT™ Admiral™ ADM06012013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall1 death7 reports
• IN.PACT™ Admiral™ ADM05020013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall5 reports
• IN.PACT™ Admiral™ ADM05004013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall1 death4 reports
• IN.PACT™ Admiral™ ADM05008013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall1 death3 reports
• IN.PACT™ Admiral™ ADM04025013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall3 reports
• IN.PACT™ Admiral™ ADM07004013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall2 reports
• IN.PACT™ Admiral™ ADM07006013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall2 reports
• IN.PACT™ Admiral™ ADM04004013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall2 reports
• IN.PACT™ Admiral™ ADM04008013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall2 reports
• IN.PACT™ Admiral™ ADM07008013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall1 report
• IN.PACT™ Admiral™ ADM05006013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 recall0 reports
• IN.PACT™ Admiral™ ADM05025013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  18 reports
• IN.PACT™ Admiral™ ADM06025013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  14 reports
• IN.PACT™ Admiral™ ADM05012013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  11 reports
• IN.PACT™ Admiral™ ADM05015013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  11 reports
• IN.PACT™ Admiral™ ADM04015008P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  9 reports
• IN.PACT™ Admiral™ ADM05015008P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  9 reports
• IN.PACT™ Admiral™ ADM04020013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  6 reports
• IN.PACT™ Admiral™ ADM06020013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  6 reports
• IN.PACT™ Admiral™ ADM06006008P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  4 reports
• IN.PACT™ Admiral™ ADM04006008P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• IN.PACT™ Admiral™ ADM04008008P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• IN.PACT™ Admiral™ ADM05012008P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• IN.PACT™ Admiral™ ADM06012008P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 death3 reports
• IN.PACT™ Admiral™ ADM06008008P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 death2 reports
• IN.PACT™ Admiral™ ADM05004008P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• IN.PACT™ Admiral™ ADM05008008P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• IN.PACT™ Admiral™ ADM06015008P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 death2 reports
• IN.PACT™ Admiral™ ADM06012013P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• IN.PACT™ Admiral™ ADM04004008P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• IN.PACT™ Admiral™ ADM04012008P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• IN.PACT™ Admiral™ ADM05006008P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• IN.PACT™ Admiral™ ADM06004008P

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report

Recent IN.PACT Admiral adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS REQUIRING REPEAT TREATMENT OCCURRED IN A PATIENT WITHIN 12 MONTHS AFTER A PROCEDURE USING AN INPACT ADMIRAL DRUG COATED BALLOON. INITIAL TREATMENT WAS (B)(6) 2025. NO EMBOLIC PROTECTION WAS USED, AND THE BALLOON WAS INFLATED USING AN INFLATION DEVICE. A NEW 6X40 INPACT AV DRUG COATED BALLOON WAS USED TO RE-TREAT AND COMPLETE THE PROCEDURE.

  Patient problems: Restenosis

  MAUDE report 25184139 ↗
• MalfunctionMay 15, 2026Deflation Problem

  IT WAS REPORTED THAT A DRUG COATED BALLOON CATHETER WAS USED DURING A PERIPHERAL ARTERY PROCEDURE INVOLVING A PLAQUE LESION IN THE MID LEFT POPLITEAL ARTERY (LESION LENGTH 250 MM; VESSEL DIAMETER 4 MM) AND DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE WITH 50/50 CONTRAST. DURING ATTEMPTED REMOVAL, THE BALLOON WAS NOT EVENTUALLY FULLY DEFLATED AND NEGATIVE PRESSURE WAS REQUIRED; IT WAS REPORTED THAT THE BALLOON DEFLATED WHEN IT WAS PULLED THROUGH THE SHEATH. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER INTERVENTIONS AS IT WAS THE END OF THE CASE.  NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25182528 ↗
• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL BALLOONS WAS USED TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT, POPLITEAL 2 SEGMENT. APPROXIMATELY 3 YEARS 5 MONTHS POST PROCEDURE PATIENT SUFFERED CRITICAL LIMB ISCHEMIA. OCCLUDED MID-FEMORAL TO MID POPLITEAL STENT (LEFT LEG) TREATED WITH ATHERECTOMY, PLAIN OLD BALLOON ANGIOPLASTY, DRUG COATED BALLOON. THE EVENT WAS ALSO TREATED WITH MEDICATION. PATIENT RECOVERED.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 24109198 ↗
• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN PACT ADMIRAL BALLOONS WAS USED TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT, POPLITEAL 2 SEGMENT. APPROXIMATELY 3 YEARS 5 MONTHS POST PROCEDURE PATIENT SUFFERED CRITICAL LIMB ISCHEMIA. OCCLUDED MID-FEMORAL TO MID POPLITEAL STENT (LEFT LEG) TREATED WITH ATHERECTOMY, PLAIN OLD BALLOON ANGIOPLASTY, DRUG COATED BALLOON. THE EVENT WAS ALSO TREATED WITH MEDICATION. PATIENT RECOVERED.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 24109193 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OF A LESION IN THE PATIENTS ARTERIOVENOUS FISTULA (AVF) OCCURRED WITHIN SEVEN MONTHS AFTER TREATMENT WITH AN INPACT ADMIRAL DRUG COATED BALLOON. A NEW INPACT AV DRUG COATED BALLOON WAS USED FOR RETREATMENT. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Restenosis

  MAUDE report 23508460 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT'S RADIAL ARTERY WAS TREATED USING AN IN. PACT ADMIRAL DRUG COATED BALLOON ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED NORMALLY; HOWEVER, THE PATIENT'S SYMPTOMS RELAPSED ON FOLLOW-UP, NECESSITATING THE USE OF A SECOND IN. PACT ADMIRAL DRUG COATED BALLOON FOR A SUBSEQUENT PROCEDURE ON (B)(6) 2025. NO ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Restenosis

  MAUDE report 23413203 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT NEEDED RETREATMENT WITHIN 12 MONTHS AFTER A PROCEDURE USING AN INPACT ADMIRAL DRUG COATED BALLOON. INITIAL TREATMENT WAS (B)(6) 2025. A NEW INPACT AV DRUG COATED BALLOON WAS USED TO RE-TREAT.

  Patient problems: Restenosis

  MAUDE report 23074331 ↗
• MalfunctionSep 15, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A CALCIFIED LESION IN THE MID AND DISTAL LEFT SUPERFICIAL FEMORAL ARTERY, THE IN. PACT ADMIRAL EACH BURST AT 2 ATM PRESSURE ON THE FIRST INFLATION. THE VESSEL WAS PRE-DILATED PRIOR TO USE OF BOTH DEVICES, AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING EITHER DEVICE. THERE WERE NO ABNORMALITIES IN ANATOMY. THE BALLOONS DID NOT DETACH DURING THE EVENT, AND BOTH DEVICES WERE SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048847 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 2 IN.PACT ADMIRAL BALLOONS WERE USED TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT, POPLITEAL 2 SEGMENT. A 3RD IN.PACT ADMIRAL BALLOON WAS USED TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT. APPROXIMATELY 4 YEARS AND 1 MONTH POST PROCEDURE PATIENT SUFFERED LEFT LOWER EXTREMITY CRITICAL LIMB ISCHEMIA OF TARGET LIMB INVOLVING TARGET LESION/VESSEL AND NON-TARGET LESION/VESSEL. OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY, POPLITEAL, PERONEAL, POSTERIOR TIBIAL AND ANTERIOR TIBIAL ARTERIES. THE EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. PATIENT RECOVERED.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 22963583 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 2 IN.PACT ADMIRAL BALLOONS WERE USED TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT, POPLITEAL 2 SEGMENT. A 3RD IN.PACT ADMIRAL BALLOON WAS USED TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT. APPROXIMATELY 4 YEARS AND 1 MONTH POST PROCEDURE PATIENT SUFFERED LEFT LOWER EXTREMITY CRITICAL LIMB ISCHEMIA OF TARGET LIMB INVOLVING TARGET LESION/VESSEL AND NON-TARGET LESION/VESSEL. OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY, POPLITEAL, PERONEAL, POSTERIOR TIBIAL AND ANTERIOR TIBIAL ARTERIES. THE EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. PATIENT RECOVERED.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 22963439 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN IN.PACT ADMIRAL BALLOON WAS USED TO TREAT THE RIGHT SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT. APPROXIMATELY 25 MONTHS POST PROCEDURE PATIENT SUFFERED RESTENOSIS OF RIGHT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL. PATIENT HAD FOLLOW-UP WITH VASCULAR GROUP FOR LEFT LEG. REPORTING RIGHT LEG PAIN. ULTRA SOUND COMPLETED AND NOTING RIGHT SUPERFICIAL FEMORAL ARTERY STENTS WERE OCCLUDED THEREFORE SCHEDULED FOR PROCEDURE. PATIENT HAD THE FOLLOWING COMPLETED: RIGHT FEMORAL ENDARTERECTOMY, RIGHT SUPERFICIAL FEMORAL ARTERY ANGIOPLASTY, POPLITEAL ANGIOPLASTY AND STENTING, RIGHT COMMON ILIAC ANGIOPLASTY AND STENTING, RIGHT EXTERNAL ILIAC ANGIOPLASTY AND STENTING, RIGHT EXTERNAL ILIAC ANGIOPLASTY AND STENTING (RIGHT: LEG) WHICH INVOLVED TARGET LESIONS. PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 22955821 ↗
• MalfunctionAug 12, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A SEVERELY CALCIFIED LESION (90% STENOSIS, 250 MM LENGTH, 5 MM DIAMETER) IN THE MID RIGHT S UPERFICIAL FEMORAL ARTERY USING THE INPACT ADMIRAL DRUG COATED BALLOON ADM05025013P 05.00 L250 UL1300 US, THERE WAS A 20-MINUTE DELAY IN SURGERY DUE TO PRODUCT MALFUNCTION. REMOVAL DIFFICULTIES OCCURRED WHEN THE BALLOON CATHETER CAUGHT UPON THE 45CM 7FR NON-MEDTRO NIC SHEATH DURING WITHDRAWAL, AND THE BALLOON TORE. THE VESSEL WAS PRE-DILATED WITH A 5X200 NON-MEDTRONIC DEVICE AND POST-DILATED WITH AN ADMIRAL 5X250 DEVICE. EMBOLIC PROTECTION WAS USED WITH A 0.014 SPIDER FX FILTER WIRE, AND THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED 6X200 PROTEGE EVERFLEX STENT. THE BALLOON WAS INFLATED USING A NON-MEDTRONIC INFLATION DEVICE WITH 50/50 CONTRAST. THE DEVICE WAS SAFELY REMOVED WITHOUT INTERVENTION WITH SHEATH AND WIRE ACCESS STILL IN PLACE. THE PROCEDURE WAS FINISHED AND CLOSED WITH ANGIOSEAL. THERE WAS NO VESSEL DAMAGE NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783028 ↗
• MalfunctionJun 18, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY DISEASE PROCEDURE TO TREAT A CALCIFIED LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY, THE INPACT ADMIRAL DRUG COATED BALLOON 018 BURST DURING THE PROCEDURE. THE COMMON FEMORAL ARTERY WAS DESCRIBED AS HIGHLY CALCIFIED, AND VESSEL PREPARATION WAS PERFORMED USING A 7MM NON-MEDTRONIC DEVICE. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST FLUID FOR INFLATION. AFTER THE FIRST DRUG COATED BALLOON BURST ON INITIAL INFLATION, A SECOND INPACT ADMIRAL DRUG COATED BALLOON WAS USED, WHICH ALSO BURST. THE DEVICES WERE SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AFTER THE SECOND BALLOON BURST. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22267837 ↗
• MalfunctionJun 13, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY USING THE IN.PACT ADMIRAL DEVICE, THE BALLOON BURST ON THE FIRST INFLATION AT, BELOW, OR AT AN UNKNOWN RATED BURST PRESSURE, LEADING TO THE PROCEDURE BEING ABORTED. THE VESSEL HAD BEEN PRE-DILATED WITH A 7MM NON-MEDTRONIC DEVICE, AND A 6X45 NON-MEDTRONIC SHEATH AND 014X300 NON-MEDTRONIC GUIDEWIRE WERE USED. INFLATION WAS PERFORMED WITH A NON-MEDTRONIC DEVICE USING 50/50 CONTRAST. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201337 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN. PACT ADMIRAL BALLOONS WERE USED TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT, POPLITEAL 2 SEGMENT. APPROXIMATELY 33 MONTHS POST PROCEDURE PATIENT SUFFERED CRITICAL LIMB ISCHEMIA OF TARGET LIMB INVOLVING TARGET LESION/VESSEL. PATIENT WAS TREATED WITH PERCUTANEOUS INTE RETENTION. TOTALLY OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY (SFA) (TARGET LESION), SUB TOTALLY OCCLUDED MID P2 SEGMENT (TARGET LESION), TOTALLY OCCLUDED ANTERIOR/POSTERIOR TIBIAL ARTERY. PATIENT RECOVERED.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 21739556 ↗

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