Zenith Alpha G35359Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10827002353593), received between Dec 15, 2020 and Jan 14, 2022 — classified as 2 deaths, 12 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (P140016); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THERE APPEARS TO BE A TYPE 1A ENDOLEAK AT THE PROXIMAL END OF THE ALPHA THORACIC GRAFT, JUST DISTAL TO THE L. SUBCLAVIAN ARTERY (LSA). THE FINAL SET OF IMAGES WE HAVE ARE FROM (B)(6) 2019, AND THESE SHOW THAT THE PROXIMAL TYPE 1A ENDOLEAK HAS BEEN FIXED BY EXTENDING THE ALPHA GRAFT PROXIMALLY TO COVER THE LSA, THE LSA ITSELF HAS BEEN COIL EMBOLIZED TO PREVENT BACKFLOW, AND THE EXTENSION OF THE GRAFT BACK INTO THE ARCH HAS BEEN FIXED USING APTUS SCREWS INTO THE AORTIC WALL. (B)(6) 2019: PROXIMAL EXTENSION OF THORACIC ENDOGRAFT WITH A COOK ZTA-PT 42 X 38 COVERING THE LEFT SUBCLAVIAN ARTERY, PLACEMENT OF THORACIC ENDOGRAFT COOK ZTA-P 38 X 167 BETWEEN THE CONNECTION OF THE PREVIOUS TEVAR AND BRANCH GRAFT. PLACEMENT OF 3 APTUS SCREWS IN THE PROXIMAL THORACIC STENT GRAFT. COIL EMBOLIZATION OF LEFT SUBCLAVIAN ARTERY. PER (B)(6) (MANUFACTURER REPORT # 3002808486-2021-01881): ON (B)(6) 2019: PROXIMAL EXTENSION OF THORACIC ENDOGRAFT WITH A COOK ZTA-PT 42 X 38 COVERING THE LEFT SUBCLAVIAN ARTERY, PLACEMENT OF THORACIC ENDOGRAFT COOK ZTA-P 38 X 167 BETWEEN THE CONNECTION OF THE PREVIOUS TEVAR AND BRANCH GRAFT. PLACEMENT OF 3 APTUS SCREWS IN T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13260598 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THERE APPEARS TO BE A TYPE 1A ENDOLEAK AT THE PROXIMAL END OF THE ALPHA THORACIC GRAFT, JUST DISTAL TO THE L. SUBCLAVIAN ARTERY (LSA). THE FINAL SET OF IMAGES WE HAVE ARE FROM (B)(6) 2019, AND THESE SHOW THAT THE PROXIMAL TYPE 1A ENDOLEAK HAS BEEN FIXED BY EXTENDING THE ALPHA GRAFT PROXIMALLY TO COVER THE LSA, THE LSA ITSELF HAS BEEN COIL EMBOLIZED TO PREVENT BACKFLOW, AND THE EXTENSION OF THE GRAFT BACK INTO THE ARCH HAS BEEN FIXED USING APTUS SCREWS INTO THE AORTIC WALL. ON (B)(6) 2019: PROXIMAL EXTENSION OF THORACIC ENDOGRAFT WITH A COOK ZTA-PT 42 X 38 COVERING THE LEFT SUBCLAVIAN ARTERY, PLACEMENT OF THORACIC ENDOGRAFT COOK ZTA-P 38 X 167 BETWEEN THE CONNECTION OF THE PREVIOUS TEVAR AND BRANCH GRAFT. PLACEMENT OF 3 APTUS SCREWS IN THE PROXIMAL THORACIC STENT GRAFT. COIL EMBOLIZATION OF LEFT SUBCLAVIAN ARTERY. PER (B)(4) (MANUFACTURER REPORT # 3002808486-2021-01881): (B)(6) 2019: PROXIMAL EXTENSION OF THORACIC ENDOGRAFT WITH A COOK ZTA-PT 42 X 38 COVERING THE LEFT SUBCLAVIAN ARTERY, PLACEMENT OF THORACIC ENDOGRAFT COOK ZTA-P 38 X 167 BETWEEN THE CONNECTION OF THE PREVIOUS TEVAR AND BRANCH GRAFT. PLACEMENT OF 3 APTUS SCREWS IN T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13151228 ↗
• DeathNov 3, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: COMPLETE DEBRANCHING OF THE AORTIC ARCH ALL VESSELS RE-LOCATED TO THE ASCENDING AORTA VIA OPEN REPAIR LANDING THE ALPHA THORACIC GRAFT IN THE ASCENDING AORTA AT THE ANASTOMOSIS OF ARCH BRANCH VESSELS. PHYSICIAN PULLED THE DEVICE SHEATH AND PATIENT BECAME HYPOTENSIVE, PHYSICIAN INSERTED A 20FR SHEATH AND PATIENT BECAME SO SICK THAT THEY NEEDED TO GO ON CARDIO PULMONARY BYPASS THEN CPR NEEDED TO BE PERFORMED AND PATIENT PUT ON CIRCULATORY ARREST. BECAUSE OF CPR THE SUTURES OF THE ANASTOMOSIS IN THE ARCH BROKE REQUIRING THE ANASTOMOSIS TO BE REDONE. THE 20FR SHEATH WAS REPLACED WITH A 21FR CANNULA USED FOR THE BYPASS MACHINE. SURGEON HAD TO OPEN ABDOMEN BECAUSE PATIENT HAD DEVELOPED INTRABDOMINAL COMPARTMENT SYNDROME DUE TO ALL THE FLUIDS HE RECEIVED THROUGH OUT CASE. WHEN THEY PULLED THE SHEATH THE FINAL TIME HIS PRESSURES PLUMMETED AGAIN AND IT BECAME CLEAR HE HAD A SIGNIFICANT RETROPERITONEAL BLEED. INJURY TO EXTERNAL ILIAC ARTERY BELIEVED TO BE CAUSED BY THE DELIVERY SYSTEM EVEN THOUGH DELIVERED OVER A LUNDERQUIST WIRE. ADDITIONAL INFORMATION RECEIVED 18-OCT-2021: WE HAD A THORACIC ENDOGRAFT GOING UP WITH FIXED IMAGES AFTER OUR I

  Patient problems: Perforation of Vessels

  MAUDE report 12743746 ↗
• InjuryOct 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "COMPONENT SEPARATION. SECONDARY PROCEDURE DONE. (SEPARATION BETWEEN ALPHA 38 AND MAIN BODY). ON (B)(6) 2017:THORACIC ENDOGRAFT (ALPHA 38X167). RIGHT GROIN CUTDOWN. ULTRASOUND-GUIDED ACCESS OF LEFT COMMON FEMORAL ARTERY. (B)(4). ON (B)(6) 2018: COMPONENT SEPARATION SEEN ON X-RAY. ON (B)(6) 2018: TEVAR RE-LINING DISTAL DTA BETWEEN PREVIOUS TEVAR AND FENESTRATED ENDOGRAFTS WITH 40X150MM GORE CTAG. ((B)(4)). PATIENT OUTCOME: PATIENT TOLERATED THE PROCEDURES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12713206 ↗
• InjuryOct 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "COMPONENT SEPARATION." "(B)(6) 2019: PROXIMAL EXTENSION OF THORACIC ENDOGRAFT WITH A COOK ZTA-PT 42 X 38 COVERING THE LEFT SUBCLAVIAN ARTERY, PLACEMENT OF THORACIC ENDOGRAFT COOK ZTA-P 38 X 167 BETWEEN THE CONNECTION OF THE PREVIOUS TEVAR AND BRANCH GRAFT. PLACEMENT OF 3 APTUS SCREWS IN THE PROXIMAL THORACIC STENT GRAFT. COIL EMBOLIZATION OF LEFT SUBCLAVIAN ARTERY. BALLOON ANGIOPLASTY OF SUPERIOR MESENTERIC ARTERY STENT AND LEFT RENAL ARTERY STENT WITH A 10 X 2 BALLOON." PATIENT OUTCOME: PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12698867 ↗
• DeathOct 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: COMPLETE DEBRANCHING OF THE AORTIC ARCH ALL VESSELS RE-LOCATED TO THE ASCENDING AORTA VIA OPEN REPAIR LANDING THE ALPHA THORACIC GRAFT IN THE ASCENDING AORTA AT THE ANASTOMOSIS OF ARCH BRANCH VESSELS. PHYSICIAN PULLED THE DEVICE SHEATH AND PATIENT BECAME HYPOTENSIVE, PHYSICIAN INSERTED A 20FR SHEATH AND PATIENT BECAME SO SICK THAT THEY NEEDED TO GO ON CARDIO PULMONARY BYPASS THEN CPR NEEDED TO BE PERFORMED AND PATIENT PUT ON CIRCULATORY ARREST. BECAUSE OF CPR THE SUTURES OF THE ANASTOMOSIS IN THE ARCH BROKE REQUIRING THE ANASTOMOSIS TO BE REDONE. THE 20FR SHEATH WAS REPLACED WITH A 21FR CANNULA USED FOR THE BYPASS MACHINE. SURGEON HAD TO OPEN ABDOMEN BECAUSE PATIENT HAD DEVELOPED INTRABDOMINAL COMPARTMENT SYNDROME DUE TO ALL THE FLUIDS HE RECEIVED THROUGH OUT CASE. WHEN THEY PULLED THE SHEATH THE FINAL TIME HIS PRESSURES PLUMMETED AGAIN AND IT BECAME CLEAR HE HAD A SIGNIFICANT RETROPERITONEAL BLEED. INJURY TO EXTERNAL ILIAC ARTERY BELIEVED TO BE CAUSED BY THE DELIVERY SYSTEM EVEN THOUGH DELIVERED OVER A LUNDERQUIST WIRE. ADDITIONAL INFORMATION RECEIVED 18OCT2021: WE HAD A THORACIC ENDOGRAFT GOING UP WITH FIXED IMAGES AFTER OUR INI

  Patient problems: Cardiac Arrest; Perforation of Vessels

  MAUDE report 12671412 ↗
• InjuryOct 18, 2021Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  PROCEDURE DATE (B)(6) 2016. COMPONENT SEPARATION DATE (B)(6) 2021.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12645914 ↗
• InjuryOct 18, 2021Off-Label Use; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Off-Label Use; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION 25JAN2022: PROCEDURE DATE (B)(6) 2017. CT DATE (B)(6) 2017 NUMBER OF STENTS OVERLAP 2. CT DATE (B)(6) 2018 NUMBER OF STENTS OVERLAP 1,5. CT DATE (B)(6) 2019 NUMBER OF STENTS OVERLAP 0. COMPONENT SEPARATION DATE (B)(6) 2019.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12645619 ↗
• InjuryMar 11, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PER THE FINDINGS IN THE IMAGING REVIEW: THE THREE SUPERIOR APICES OF THE ZTA-P-38-167-W DISTAL STENT SEGMENT WERE INVERTED DISTALLY INTO THE LUMEN. TWO MARKERS WERE ALSO BUNCHED FROM STENT WIRES SLIDING THROUGH THEIR SUTURES. PATIENT SUBMITTED TO THE HOSPITAL TUESDAY (B)(6) 2020, WITH CHEST PAIN FOLLOWING A TEVAR ON (B)(6) 2020. CT REVEALED POSSIBLE TYPE 1A ENDOLEAK AT THE LSA (PROX EDGE OF INITIAL GRAFT ZTA-PT-38-34-217-W) ((B)(6)). THE DOCTOR CALLED ME 25NOV2020 WITH A PLAN TO EXTEND PROXIMALLY WITH A SHORT 36 OR 38MM ALPHA. HE INDICATED THAT HE BEGIN WITH LSA/LCC BYPASS ALONG WITH A VBX ¿SNORKEL¿ THROUGH THE LCC VIA THE LEFT ARM SO HE COULD EXTEND THE PROXIMAL EDGE OF THE GRAFT OVER THE LCC TO THE INNOMINATE. THIS PLAN WAS PUT INTO EFFECT AND HE POSITIONED A ZTA-P-38-167-W OVER A 300 COUBLE CURVED LUNDERQUIST AND INITIATED DEPLOYMENT OF THE GRAFT AFTER AORTOGRAM AND MARKING OF LANDMARKS. THE INITIAL DEPLOYMENT WENT ACCORDING TO PLAN WITH THE POSITIONED RIGHT AT THE DISTAL EDGE OF THE INNOMINATE ARTERY. HOWEVER, IN THE NEXT INSTANT THE GRAFT WAS FULLY DEPLOYED AND 3CM PAST THE INNOMINATE INTO THE ASCENDING AORTA. THE AORTIC LUME

  Patient problems: Insufficient Information

  MAUDE report 11462566 ↗
• InjuryMar 10, 2021Malposition of Device; Malposition of Device

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PER THE FINDINGS IN THE IMAGING REVIEW: THE PROVIDED POST IMPLANTATION CTA PERFORMED SIX DAYS AFTERWARDS CONFIRMS THE SUSPECTED A TYPE IA ENDOLEAK. THIS ENDOLEAK EXTENDED BETWEEN THE SNORKELED STENTS AND FLOWED INTO THE OUTER AORTIC CURVATURE HEMATOMA WHERE THE TRAILING EDGE OF THE LSA MET THE LEADING EDGE OF THE ORIGINAL ZTA-P (ZTA-PT-38-34-217- W) SEALING STENT. ALTHOUGH THE ENTRY SITE WAS NEW COMPARED TO THE INITIAL PENETRATION SITE, THE LEAK WAS INTO THE SAME INTRAMURAL SPACE, OR FALSE LUMEN, AS THE ORIGINAL LEAK. ((B)(4)) PATIENT SUBMITTED TO THE HOSPITAL TUESDAY (B)(6) 2020, WITH CHEST PAIN FOLLOWING A TEVAR ON (B)(6) 2020. CT REVEALED POSSIBLE TYPE 1A ENDOLEAK AT THE LSA (PROX EDGE OF INITIAL GRAFT ZTA-PT-38-34-217-W) ((B)(4)). THE DOCTOR CALLED ME (B)(6) 2020 WITH A PLAN TO EXTEND PROXIMALLY WITH A SHORT 36 OR 38MM ALPHA. HE INDICATED THAT HE BEGIN WITH LSA/LCC BYPASS ALONG WITH A VBX ¿SNORKEL¿ THROUGH THE LCC VIA THE LEFT ARM SO HE COULD EXTEND THE PROXIMAL EDGE OF THE GRAFT OVER THE LCC TO THE INNOMINATE. THIS PLAN WAS PUT INTO EFFECT AND HE POSITIONED A ZTA-P-38-167-W OVER A 300 COUBLE CURVED LUNDERQUIST AND INITIATED D

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11452728 ↗
• InjuryFeb 22, 2021Off-Label Use; Loosening of Implant Not Related to Bone-Ingrowth; Material Too Soft/Flexible; Off-Label Use; Loosening of Implant Not Related to Bone-Ingrowth; Material Too Soft/Flexible

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PER THE FINDINGS IN THE IMAGING REVIEW: THE THREE SUPERIOR APICES OF THE ZTA-P-38-167-W DISTAL STENT SEGMENT WERE INVERTED DISTALLY INTO THE LUMEN. TWO MARKERS WERE ALSO BUNCHED FROM STENT WIRES SLIDING THROUGH THEIR SUTURES. PATIENT SUBMITTED TO THE HOSPITAL TUESDAY (B)(6) 2020, WITH CHEST PAIN FOLLOWING A TEVAR ON (B)(6) 2020. CT REVEALED POSSIBLE TYPE 1A ENDOLEAK AT THE LSA (PROX EDGE OF INITIAL GRAFT ZTA-PT-38-34-217-W) ((B)(6)). THE DOCTOR CALLED ME (B)(6) 2020 WITH A PLAN TO EXTEND PROXIMALLY WITH A SHORT 36 OR 38MM ALPHA. HE INDICATED THAT HE BEGIN WITH LSA/LCC BYPASS ALONG WITH A VBX ¿SNORKEL¿ THROUGH THE LCC VIA THE LEFT ARM SO HE COULD EXTEND THE PROXIMAL EDGE OF THE GRAFT OVER THE LCC TO THE INNOMINATE. THIS PLAN WAS PUT INTO EFFECT AND HE POSITIONED A ZTA-P-38-167-W OVER A 300 COUBLE CURVED LUNDERQUIST AND INITIATED DEPLOYMENT OF THE GRAFT AFTER AORTOGRAM AND MARKING OF LANDMARKS. THE INITIAL DEPLOYMENT WENT ACCORDING TO PLAN WITH THE POSITIONED RIGHT AT THE DISTAL EDGE OF THE INNOMINATE ARTERY. HOWEVER, IN THE NEXT INSTANT THE GRAFT WAS FULLY DEPLOYED AND 3CM PAST THE INNOMINATE INTO THE ASCENDING AORTA. THE AORTIC LU

  Patient problems: Insufficient Information; No Information

  MAUDE report 11356929 ↗
• InjuryFeb 22, 2021Off-Label Use; Malposition of Device; Off-Label Use; Malposition of Device

  PATIENT OUTCOME: THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? CANNULATION, (VBX) STENT-GRAFT VIA RIGHT ARM).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 11356923 ↗
• InjuryDec 21, 2020Off-Label Use; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Off-Label Use; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT SUBMITTED TO THE HOSPITAL ON TUESDAY (B)(6) 2020, WITH CHEST PAIN FOLLOWING A TEVAR ON (B)(6) 2020. CT REVEALED POSSIBLE TYPE 1A ENDOLEAK AT THE LSA (PROX EDGE OF INITIAL GRAFT ZTA-PT-38-34-217-W). IT WAS PLANED TO EXTEND PROXIMALLY WITH A SHORT 36 OR 38MM ALPHA. IT WAS INDICATED TO BEGIN WITH LSA/LCC BYPASS ALONG WITH A VBX "SNORKEL" THROUGH THE LCC VIA THE LEFT ARM TO EXTEND THE PROXIMAL EDGE OF THE GRAFT OVER THE LCC TO THE INNOMINATE. THIS PLAN WAS PUT INTO EFFECT AND A ZTA-P-38-167-W WAS POSITIONED OVER A 300 COUBLE CURVED LUNDERQUIST AND INITIATED DEPLOYMENT OF THE GRAFT AFTER AORTOGRAM AND MARKING OF LANDMARKS. THE INITIAL DEPLOYMENT WENT ACCORDING TO PLAN WITH THE POSITIONED RIGHT AT THE DISTAL EDGE OF THE INNOMINATE ARTERY. HOWEVER, IN THE NEXT INSTANT THE GRAFT WAS FULLY DEPLOYED AND 3CM PAST THE INNOMINATE INTO THE ASCENDING AORTA. THE AORTIC LUMEN IN THIS AREA WAS APPROXIMATELY 40MM AND ANESTHESIA CONFIRMED ON MULTIPLE OCCASIONS THAT THERE WERE NO CONCERNING CHANGES IN BLOOD PRESSURE OR OTHERWISE WITH PATIENT THROUGHOUT THE REST OF THE CASE. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO PULL THE DEVICE BACK, SO HE

  Patient problems: Chest Pain; Insufficient Information

  MAUDE report 11044281 ↗
• InjuryDec 15, 2020Unintended Movement; Unintended Movement

  ACCORDING TO THE COMPANY REPRESENTATIVE, "PATIENT SUBMITTED TO THE HOSPITAL TUESDAY (B)(6) 2020, WITH CHEST PAIN FOLLOWING A TEVAR ON (B)(6) 2020. CT REVEALED POSSIBLE TYPE 1A ENDOLEAK AT THE LSA (PROX EDGE OF INITIAL GRAFT ZTA-PT-38-34-217-W). THE PHYSICIAN CALLED ME (B)(6) 2020 WITH A PLAN TO EXTEND PROXIMALLY WITH A SHORT 36 OR 38MM ALPHA. HE INDICATED THAT HE BEGIN WITH LSA/LCC BYPASS ALONG WITH A VBX ¿SNORKEL¿ THROUGH THE LCC VIA THE LEFT ARM SO HE COULD EXTEND THE PROXIMAL EDGE OF THE GRAFT OVER THE LCC TO THE INNOMINATE. THIS PLAN WAS PUT INTO EFFECT AND HE POSITIONED A ZTA-P-38-167-W OVER A 300 COUBLE CURVED LUNDERQUIST AND INITIATED DEPLOYMENT OF THE GRAFT AFTER AORTOGRAM AND MARKING OF LANDMARKS. THE INITIAL DEPLOYMENT WENT ACCORDING TO PLAN WITH THE POSITIONED RIGHT AT THE DISTAL EDGE OF THE INNOMINATE ARTERY. HOWEVER, IN THE NEXT INSTANT THE GRAFT WAS FULLY DEPLOYED AND 3CM PAST THE INNOMINATE INTO THE ASCENDING AORTA. THE AORTIC LUMEN IN THIS AREA WAS APPROXIMATELY 40MM AND ANESTHESIA CONFIRMED ON MULTIPLE OCCASIONS THAT THERE WERE NO CONCERNING CHANGES IN BLOOD PRESSURE OR OTHERWISE WITH PATIENT THROUGHOUT THE REST OF THE CASE. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED P

  Patient problems: No Code Available

  MAUDE report 11010721 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140016. One submission often covers many models, so check the product and lot details in each record.

• Z-0043-2026 · Sep 18, 2025 · Open, Classified
  Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W
• Z-2099-2017 · Mar 22, 2017 · Terminated
  Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descend