VenaSealRecalls & reported problems across all models

We found 2 models of VenaSeal by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 200 adverse event reports in the FDA's MAUDE database, received between Mar 16, 2018 and Jul 21, 2026 — classified as 4 deaths, 178 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (104 reports).

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

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

VenaSeal 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, 2021Terminated

   Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.

   Z-1564-2021 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

Most reported VenaSeal problems

VenaSeal models

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

• VenaSeal™ VS-404

  Agent, occluding, vascular, permanent
  1 recall2 deaths135 reports
• VenaSeal™ VS-402

  Agent, occluding, vascular, permanent
  1 recall2 deaths65 reports

Recent VenaSeal adverse event reports

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

• MalfunctionJul 21, 2026Delivered as Unsterile Product; Device Difficult to Setup or Prepare; Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25886563 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING TREATMENT WITH THE VENASEAL CLOSURE SYSTEM, A PATIENT WAS IDENTIFIED AS HAVING A PROBABLE GLUE EXTENSION CONSISTENT WITH EHIT KABNICK CLASS 2, WITH PROPAGATION APPROXIMATELY 1 CM INTO THE COMMON FEMORAL VEIN AND OCCUPYING ABOUT 11% OF THE COMMON FEMORAL VEIN LUMEN. THE EVENT WAS REPORTED IN THE LEFT GREAT SAPHENOUS VEIN. MULTIPLE ULTRASOUND EXAMINATIONS WERE PERFORMED AND SHOWED NO CHANGE IN THE THROMBUS OR GLUE OVER AN APPROXIMATELY 6-WEEK PERIOD. MEDICAL INTERVENTION WAS PROVIDED WITH PRESCRIPTION PLAVIX FOR APPROXIMATELY 6 WEEKS. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC AND ALIVE WITH NO INJURY, AND THE THROMBUS OR GLUE WAS REPORTED TO STILL BE PRESENT. THE CLINIC DID NOT CONFIRM THE COMPLICATION UNTIL THE 6 WEEK FOLLOW UP. AT THAT TIME THE GLUE WAS STABLE, AND THE PATIENT WAS ASYMPTOMATIC, SO THEY WERE NOT DOING ANY FOLLOW UP. THE PATIENT IS NOT RECEIVING FURTHER TREATMENT, ISSUE IS STILL PRESENT BUT STABLE. CLINICIAN IS NOT TRACKING IT ANYMORE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25886411 ↗
• InjuryJul 7, 2026Nonstandard Device

  IT WAS REPORTED THAT A VENASEAL PROCEDURE WAS PERFORMED FOR VENOUS INSUFFICIENCY INVOLVING THE BILATERAL GREAT SAPHENOUS VEINS AND B ILATERAL SMALL SAPHENOUS VEINS. TWO VENASEAL KITS WERE USED DURING THE PROCEDURE. THERE WERE NO CHALLENGES OR DEVIATIONS RELATED TO LOCATION OF CATHETER TIP PRIOR TO INITIAL DELIVERY OF ADHESIVE. THE CATHETER TIP WAS 5CM CAUDAL TO SPJ. COMPRESSION OF SSV WAS UTILIZED. AT AN APPROXIMATELY 72-HOUR ULTRASOUND FOLLOW-UP, A NON-OCCLUSIVE THROMBUS EXTENSION FROM THE RIGHT SMALL SAPHENOUS VEIN INTO THE POPLITEAL VEIN WAS IDENTIFIED AND WAS REPORTED AS EGIT 3 WITH AN EXTENSION OF APPROXIMATELY 4.78 CM, AND THERE WAS UNCERTAINTY WHETHER THE FINDING REPRESENTED GLUE EXTENSION OR THROMBUS. THE ULTRASOUND TECHNOLOGIST STATED THEY DID NOT THINK THE FINDING WAS GLUE EXTENSION. THE PHYSICIAN REPORTED A CONCERN THAT SOMETHING WAS WRONG WITH THE DELIVERY GUN AND THAT IT DELIVERED MORE GLUE THAN INTENDED. ANTICOAGULATION THERAPY WAS INITIATED AND THE PATIENT WAS PRESCRIBED ELIQUIS. AT A SUBSEQUENT ULTRASOUND AND PHYSICIAN VISIT APPROXIMATELY ONE WEEK LATER, THE THROMBUS EXTENSION INTO THE POPLITEAL VEIN WAS REPORTED TO HAVE REGRESSED TO APPROXIMATELY 4.41 CM AND REMAIN

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25732525 ↗
• InjuryApr 13, 2026Biocompatibility

  A PHYSICIAN USED A VENASEAL CLOSURE SYSTEM DURING AN ABLATION PROCEDURE OF THE PATIENTS LEFT GREAT SAPHENOUS VEIN (GSV) AND ANTERIOR ACCESSORY SAPHENOUS VEIN (AASV) ON (B)(6) 2025. POST-OP, THE PATIENT HAD AN ALLERGIC REACTION TO THE VENASEAL. THE PATIENT PRESENTED ON 18-(B)(6) 2025 WITH PAIN AND ERYTHEMA OF THE MEDIAL THIGH, NOT ASSOCIATED WITH ANY INCISIONS. ULTRASOUND SHOWED SOME CLOT IN BRANCH VARICOSITIES. THE PATIENT WAS STARTED ON DOXYCYCLINE FOR BOTH ANTIMICROBIAL AND ANTI-INFLAMMATORY PROPERTIES. THE PATIENT RETURNED ON (B)(6) 2025 WITH ERYTHEMA AND DISCOLORATION ON THE MEDIAL LEG DOWN TO THE ANKLE AND TO A LESSER EXTENT ON THE ANTERIOR THIGH. ULTRASOUND AGAIN SHOWED SOME BRANCH VEIN THROMBOSIS BUT NOT ENOUGH TO ACCOUNT FOR THE CLINICAL APPEARANCE. THERE WAS NO EVIDENCE OF ABSCESS OR OTHER SIGN OF INFECTION. THE PHYSICIAN SENT THE PATIENT TO THE LAB FOR A COMPLETE BLOOD COUNT (CBC), ERYTHROCYTE SEDIMENTATION RATE (ESR), C-REACTIVE PROTEIN (CRP), AND PRO-CALCITONIN TESTS. ALL TESTS WERE NORMAL EXCEPT THE CRP WHICH WAS 117 (NORMAL 5). THE PATIENT WAS STARTED ON PREDNISONE 5MG BY MOUTH DAILY UNTIL THE CRP NORMALIZED, WHICH TOOK ABOUT 6 WEEKS. AT THAT TIME THE PHYSICIAN PERFOR

  Patient problems: Erythema; Local Reaction; Pain; Skin Discoloration; Thrombosis/Thrombus

  MAUDE report 24858146 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A PROCEDURE USING THE VENASEAL CLOSURE SYSTEM TO TREAT A SOFT TISSUE LESION IN THE PATIENTS LEFT PROXIMAL GREAT SAPHENOUS VEIN, THE PATIENT EXPERIENCED GROIN PAIN THAT WAS NOTED AT AN INITIAL FOLLOW-UP ULTRASOUND SCAN. THE ONSET OF SYMPTOMS WAS DAYS 2-14 AFTER PROCEDURE. THE INITIAL FOLLOW-UP SCAN REPORTEDLY SHOWED NO OCCLUSION, AND THE PHYSICIAN INSTRUCTED THE PATIENT TO TAKE BABY ASPIRIN. AT A SUBSEQUENT FOLLOW-UP ULTRASOUND SCAN ON (B)(6) 2026, THROMBUS/OCCLUSION WAS IDENTIFIED. THE THROMBUS WAS REPORTED TO HAVE STARTED IN THE GREAT SAPHENOUS VEIN BETWEEN THE FIRST GLUE DELIVERY SITE AND THE SAPHENOFEMORAL JUNCTION, WITH THROMBUS EXTENSION FROM THE SAPHENOFEMORAL JUNCTION. THE THROMBUS WAS NOT IN THE DEEP VEIN. IMAGES WERE UNCLEAR AS TO WHETHER SUSPECTED EXTENSION TO THE JUNCTION REPRESENTED THROMBUS OR GLUE. THE PATIENT WAS TREATED WITH ELIQUIS FOR 30 DAYS AND THE GROIN PAIN SUBSIDED AFTER STARTING ELIQUIS.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 24843513 ↗
• InjuryMar 30, 2026Biocompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENASEAL PROCEDURE AND SUBSEQUENTLY EXPERIENCED AN ADVERSE REACTION CHARACTERIZED BY RASH AND ANAPHYLAXIS TWO WEEKS POST-OPERATION. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH ANAPHYLAXIS, WHICH WAS CONSIDERED A LIFE-THREATENING ILLNESS/INJURY AND REQUIRED HOSPITALIZATION. MEDICAL INTERVENTION INCLUDED ADMINISTRATION OF AN EPIPEN AND A STEROID PRESCRIPTION (40MG TAPER, THEN 80MG). THE REACTION OCCURRED OUTSIDE THE TREATMENT AREA AND WAS THE INITIAL REACTION EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Local Reaction; Rash

  MAUDE report 24726767 ↗
• InjuryMar 30, 2026Biocompatibility

  IT WAS REPORTED THAT FOLLOWING A PROCEDURE INVOLVING THE VENASEAL, THE PATIENT EXPERIENCED A CLINICAL REACTION CHARACTERIZED BY A RASH THAT DEVELOPED OUTSIDE THE TREATMENT AREA, SPECIFICALLY NOT IN THE AXIAL ARTERY OR VEIN. ONLY ONE LEG WAS TREATED AND THE REACTION WAS ON THAT LEG. THE ONSET OF SYMPTOMS OCCURRED BETWEEN DAYS 2 AND 14 AFTER THE PROCEDURE, AND THIS WAS THE INITIAL REACTION EVENT. THE ISSUE WAS STILL PRESENT AT THE TIME OF REPORTING. ADDITIONAL INFORMATION RECEIVED 04 MARCH 2026 MEDICAL INTERVENTION WAS REQUIRED, AND THE PATIENT WAS TREATED WITH A PRESCRIPTION STEROID (MEDTROL DOSE PACK) BUT SYMPTOMS PERSISTED. THE AFFECTED LOCATIONWAS THE PERIPHERAL VEIN(S), INCLUDING THE GREAT SAPHENOUS VEIN, WITH INVOLVEMENT NOTED IN PROXIMAL, MID, AND DISTAL SEGMENTS. NO CHALLENGES OR DEVIATIONS RELATED TO THE LOCATION OF CATHETER TIP PRIOR TO INITIAL DELIVERY OF ADHESIVE, THE CATHETER TIP WAS 5 CM CAUDAL TO SFJ AND COMPRESSION OF GSV WAS APPLIED. SYMPTOMS DID NOT RESOLVE AND THE VEIN WAS REMOVED ON 2/12 AND THE PATIENT IS REPORTED TO BE OK NOW. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hypersensitivity/Allergic reaction; Local Reaction; Rash

  MAUDE report 24712866 ↗
• MalfunctionMar 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL VEIN CLOSURE PROCEDURE OF THE GREAT SAPHENOUS VEIN (GSV)  USING THE VENASEAL CLOSURE SYSTEM VS-404, THERE WAS A DELAY IN SURGERY OF FIVE MINUTES DUE TO PRODUCT ISSUES. THE SPIN LOCK WOULD NOT STAY CLOSED DURING THE PROCEDURE, CAUSING THE GLUE DELIVERY CATHETER TO BE REPEATEDLY PULLED OUT OF THE INTRODUCER. THIS DEVICE DETACHMENT ISSUE OCCURRED WITHIN THE VESSEL, REQUIRING REMOVAL AND REPLACEMENT OF THE DEVICE DURING THE PROCEDURE. THE DEVICE WAS PUT BACK TOGETHER VIA THE SPIN LOCK AND REMOVED SAFELY FROM THE PATIENT AS WHOLE. THE PROCEDURE WAS COMPLETED USING ANOTHER VENASEAL KIT. MANUAL COMPRESSION WAS UTILIZED, THE LUMEN WAS FLUSHED PRIOR TO USE, AND A GUIDEWIRE FROM THE VS KIT WAS USED FOR CATHETER INSERTION. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE VEIN WAS SUCCESSFULLY CLOSED, AND NO SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, INJURIES, INFECTIONS, OR DEATHS WERE REPORTED.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24636688 ↗
• MalfunctionMar 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CLOSURE OF PERIPHERAL VEIN(S), SPECIFICALLY THE GREAT SAPHENOUS VEIN (GSV), USING THE VENASEAL CLOSURE SYSTEM, THE BLUE CATHETER BROKE UPON REMOVAL HALFWAY DOWN THE SHAFT. THERE WAS NO KINK AND IT OCCURRED WHILE IN THE PATIENT. IT WAS A CLEAN BREAK, STRAIGHT ACROSS. THE DEVICE WAS EXPLANTED. LOCAL ANESTHESIA WAS UTILIZED, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE VEIN CLOSURE WAS ACHIEVED. THE PROCEDURE WAS COMPLETED DESPITE THE CATHETER BREAKING UPON REMOVAL. NO PATIENT COMPLICATIONS OR INJURY HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511461 ↗
• InjuryJan 17, 2026Biocompatibility

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A VENASEAL VS-404 TO TREAT A SOFT TISSUE LESION IN THE LEFT PROXIMAL MID SHORT SAPHENOUS VEIN (SSV). PATIENT HAD AN ADHESIVE PLUG. PATIENT HAD LEFT SSV VENASEAL PROCEDURE ON ((B)(6)). PATIENT STARTED DEVELOPING OPEN WOUNDS ON THE DISTAL 1/3 OF THE LEG AROUND MID SEPTEMBER AND KEPT DEVELOPING MORE AND PROGRESSING HIGHER TO THE POPLITEAL JUNCTION REGION. PHYSICIAN SAID THEY WERE UNSURE IT WAS GRANULOMA. PHYSICIAN IS NOT THE ONE TREATING IT, BUT A DERMATOLOGIST. DERMATOLOGIST HAD TREATED THE PATIENT FOR ANTIBIOTICS FLUCLOXACILLIN FOR CELLULITIS. ACCORDING TO THE DERMATOLOGIST, PIECES OF HARD SUBSTANCES KEPT COMING OUT AND THE 3 SWAB BIOPSIES PERFORMED ALSO KEPT SHOWING UP WITH PSEUDOMONAS. PHYSICIAN SAID IF IT DID NOT HAVE PSEUDOMONAS, PHYSICIAN WOULD HAVE LEFT IT ALONE AND OBSERVED IT. SINCE THERE WAS PSEUDOMONAS, THEY PLANNED TO EXCISE AND EXPLANT THEM, THE SSV.

  Patient problems: Granuloma; Unspecified Infection

  MAUDE report 24105429 ↗
• MalfunctionDec 19, 2025Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A CLOSURE SYSTEM VS-404 VENASEAL US EA TO TREAT A LESION IN THE PROXIMAL MID GREAT SAPHENOUS VEIN (GSV). THE LUMEN FLUSHED WAS PRIOR TO USE. THE 035" GUIDE WIRE THAT COMES IN KIT WAS USED. LOCAL ANESTHESIA WAS USED. HAND/MANUAL COMPRESSION WAS USED. BLUE CATHETER COULD NOT BE SCREWED INTO WHITE DELIVERY CATHETER. DETACHMENT OF THE SCREW IN PART OF CATHETER OCCURRED. DEVICE SAFELY REMOVED FROM PATIENT. VEIN CLOSED. PROCEDURE COMPLETED WITH THE DEVICE IN QUESTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848808 ↗
• InjuryDec 10, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PATIENT WAS TREATED FOR A LESION IN THE RIGHT MID AND DISTAL GREAT SAPHENOUS VEIN WITH THE VENASEAL CLOSURE SYSTEM. POST-OP, THE PATIENT EXPERIENCED HYPERSENSITIVITY, SKIN IRRITATION, ITCHING, GRANULOMA, AS WELL AS SEVERAL ULCERATIONS ON THE RIGHT LEG. ONLY ONE LEG WAS TREATED. THIS WAS A RECURRENT PROCESS. THE BLUE INTRODUCER WAS USED. THERE WERE NO CHALLENGES OR DEVIATIONS RELATED TO LOCATION OF CATHETER TIP PRIOR TO INITIAL DELIVERY OF ADHESIVE. THE CATHETER TIP WAS 5CM CAUDAL TO SFJ. THE REACTION AND GRANULOMA OCCURRED ALONG THE TREATED VEIN, MORE THAN 5 CM FROM THE ACCESS SITE, AND THE ONSET OF SYMPTOMS WAS AT LEAST SIX MONTHS AFTER THE PROCEDURE. THE DIAMETER OF THE TREATED VEIN WAS 6.25 MM. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE ISSUE WAS STILL PRESENT AT THE TIME OF REPORTING.

  Patient problems: Granuloma; Hypersensitivity/Allergic reaction; Inflammation; Itching Sensation; Ulcer

  MAUDE report 23768118 ↗
• InjuryNov 27, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT FOLLOWING A VENASEAL CLOSURE SYSTEM PROCEDURE INVOLVING THE GREAT SAPHENOUS VEIN, A PATIENT DESCRIBED REMOVING "GRAVEL" (CHUNKS OF GLUE) FROM THEIR LEGS AND EXPERIENCED MILD INFLAMMATION AT THE AREA. A GRANULOMA WAS IDENTIFIED ALONG THE TREATED VEIN, MORE THAN 5 CM FROM THE ACCESS SITE. ULTRASOUND IMAGES AND PHOTOGRAPHS DEPICTING THE CONDITION WERE AVAILABLE. THE EVENT WAS ASSOCIATED WITH THE GREAT SAPHENOUS VEIN. IT IS UNKNOWN IF THERE WAS ANY SURGICAL OR MEDICAL INTERVENTION. THE ISSUE WAS REPORTED AS RESOLVED. THE AREA IS INFLAMED. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Granuloma

  MAUDE report 23665666 ↗
• InjuryNov 13, 2025Biocompatibility; Biocompatibility

  THE INITIAL VENASEAL PROCEDURE WAS UNEVENTFUL, BOTH AT THE PROCEDURE AND AT THE PATIENT¿S 48 HOUR POSTOPERATIVE VISIT ON (B)(6) 2025. IT WAS REPORTED DURING A ROUTINE 6 WEEK FOLLOW-UP FOLLOWING THE INITIAL IMPLANT PROCEDURE USING THE VENASEAL CLOSURE SYSTEM IN THE RIGHT GREAT SAPHENOUS VEIN, THE PATIENT EXPERIENCED HARDENING AND DISCOMFORT ALONG THE COURSE OF THE VEIN, A SMALL RED TENDER PIMPLE-LIKE AREA ON THE RIGHT MEDIAL LOWER LIMB. ON (B)(6) 2025 PATIENT CALLED THE CLINIC TO REQUEST RECOMMENDATIONS FOR BANDAGING OF PREVIOUSLY UNREPORTED OPEN SORES ALONG THE GSV. AT THAT TIME, A SCABBED SORE ALONG THE RIGHT MEDIAL UPPER CALF, AND A LARGER SCABBED SORE IN THE RIGHT MEDIAL THIGH WITH SURROUNDING REDNESS WAS NOTED. THE WOUNDS WORSENED AND BECAME MORE NUMEROUS ALONG THE GREAT SAPHENOUS VEIN, ACCOMPANIED BY SWELLING, SKIN INFLAMMATION, SKIN IRRITATION, SKIN DISCOLORATION, AND RASH. A POSSIBLE DIAGNOSIS OF PYODERMA GANGRENOSUM WAS CONSIDERED. THE PATIENT WAS TREATED WITH TOPICAL AND ORAL ANTIBIOTICS AND ZYRTEC 20MG DAILY AND WAS REFERRED TO A DERMATOLOGIST FOR FOLLOW-UP. THE TREATED VEIN WAS 53CM IN LENGTH, WITH A DIAMETER OF 4.5MM, AND 1.7ML OF ADHESIVE WAS USED. THE ISSUE REMAINED P

  Patient problems: Inflammation; Local Reaction; Rash; Skin Discoloration; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 23543238 ↗
• InjuryNov 5, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT FOLLOWING A VENASEAL PROCEDURE USING THE CLOSURE SYSTEM VS-404, THE PATIENT EXPERIENCED REDNESS AND PAIN AT THE MEDIAL THIGH WITHOUT ITCHING, SWELLING AND ITCHING OF BOTH LEGS (WORSE ON THE LEFT), AND A HYPERSENSITIVITY REACTION DIAGNOSED BY THE OFFICE.THE LEFT LEG WAS TREATED ON THE (B)(6) 2025 AND THE RIGHT LEG WAS TREATED ON THE (B)(6) 2025. THE PATIENT HAD A LESION AT THE LEFT GREAT SAPHENOUS VEIN MID SEGMENT, A LESION AT THE RIGHT LEG (TREATED, SYMPTOMS NOT SPECIFIED), AND A LESION AT A SOFT TISSUE SITE. THE PATIENT WAS TREATED WITH PRESCRIPTION ANTIBIOTICS FOR REDNESS AND IT WAS UNCLEAR AT THE TIME IF IT IS A TRUE CELLULITIS INFECTION. THE PATIENT HAS AN AUTOIMMUNE DISORDER THAT WAS UNKNOWN UNTIL FOLLOW UP VISITS. PATIENT WAS DIAGNOSED WITH HYPERSENSITIVITY AND OVER-THE-COUNTER ANTIHISTAMINE WAS PRESCRIBED FOR THE HYPERSENSITIVITY REACTION. AS OF THE LATEST FOLLOW-UP, SYMPTOMS WERE RESOLVING. NO DEATHS WERE REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Pain; Swelling/ Edema

  MAUDE report 23477229 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls