VenovoRecalls & reported problems across all models
Angiomed GmbH & Co. Medizintechnik KG · 84 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Venovo model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 428
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls
- 3
We found 84 models of Venovo by Angiomed GmbH & Co. Medizintechnik KG in the FDA's device registry (GUDID). Together they are named in 428 adverse event reports in the FDA's MAUDE database, received between May 16, 2019 and Sep 22, 2026 — classified as 23 injuries, 405 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (351 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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
Reports received per month, all models
Venovo 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.
- Dec 14, 2020Open, Classified
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Z-1899-2021 · Root cause: Under Investigation by firm · names 14 of these models · Recall details · FDA record ↗
- Dec 14, 2020Open, Classified
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Z-1898-2021 · Root cause: Under Investigation by firm · names 28 of these models · Recall details · FDA record ↗
- Dec 14, 2020Open, Classified
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Z-1897-2021 · Root cause: Under Investigation by firm · names 42 of these models · Recall details · FDA record ↗
Most reported Venovo problems
Device problems
- Activation Failure351
- Material Deformation33
- Positioning Failure28
- Fracture23
- Misfire21
- Difficult or Delayed Positioning15
- Entrapment of Device15
- Malposition of Device13
Patient problems
- No Clinical Signs, Symptoms or Conditions400
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- No Consequences Or Impact To Patient7
- Swelling/ Edema3
- Burning Sensation2
- Device Embedded In Tissue or Plaque2
- Foreign Body In Patient2
- Hypersensitivity/Allergic reaction2
Venovo models
84 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Venovo® VENUM16100Stent, iliac vein1 recall55 reports
- Venovo® VENUM14080Stent, iliac vein1 recall36 reports
- Venovo® VENUM14120Stent, iliac vein1 recall33 reports
- Venovo® VENUM14140Stent, iliac vein1 recall31 reports
- Venovo® VENUM14100Stent, iliac vein1 recall30 reports
- Venovo® VENUM16120Stent, iliac vein1 recall29 reports
- Venovo® VENUM14160Stent, iliac vein1 recall27 reports
- Venovo® VENUL14140Stent, iliac vein1 recall18 reports
- Venovo® VENUM14060Stent, iliac vein1 recall15 reports
- Venovo® VENUM16160Stent, iliac vein1 recall14 reports
- Venovo® VENUM16080Stent, iliac vein1 recall10 reports
- Venovo® VENUL14060Stent, iliac vein1 recall9 reports
- Venovo® VENUM18080Stent, iliac vein1 recall8 reports
- Venovo® VENUL14080Stent, iliac vein1 recall7 reports
- Venovo® VENUM16060Stent, iliac vein1 recall7 reports
- Venovo® VENUM20080Stent, iliac vein1 recall7 reports
- Venovo® VENUM18120Stent, iliac vein1 recall6 reports
- Venovo® VENUM20100Stent, iliac vein1 recall6 reports
- Venovo® VENUM12100Stent, iliac vein1 recall5 reports
- Venovo® VENUM16140Stent, iliac vein1 recall5 reports
- Venovo® VENUM12080Stent, iliac vein1 recall4 reports
- Venovo® VENUL14160Stent, iliac vein1 recall4 reports
- Venovo® VENUL16160Stent, iliac vein1 recall4 reports
- Venovo® VENUM18160Stent, iliac vein1 recall4 reports
- Venovo® VENUM20140Stent, iliac vein1 recall4 reports
- Venovo® VENUM12120Stent, iliac vein1 recall3 reports
- Venovo® VENUL14120Stent, iliac vein1 recall3 reports
- Venovo® VENUL16080Stent, iliac vein1 recall3 reports
- Venovo® VENUL16100Stent, iliac vein1 recall3 reports
- Venovo® VENUM18100Stent, iliac vein1 recall3 reports
- Venovo® VENUM18140Stent, iliac vein1 recall3 reports
- Venovo® VENUL18120Stent, iliac vein1 recall3 reports
- Venovo® VENUL20060Stent, iliac vein1 recall3 reports
- Venovo® VENUL12080Stent, iliac vein1 recall2 reports
- Venovo® VENUM14040Stent, iliac vein1 recall2 reports
- Venovo® VENUL14040Stent, iliac vein1 recall2 reports
- Venovo® VENUL14100Stent, iliac vein1 recall2 reports
- Venovo® VENUM16040Stent, iliac vein1 recall2 reports
- Venovo® VENUL16120Stent, iliac vein1 recall2 reports
- Venovo® VENUL18140Stent, iliac vein1 recall2 reports
- Venovo® VENUM12060Stent, iliac vein1 recall1 report
- Venovo® VENUM12140Stent, iliac vein1 recall1 report
- Venovo® VENUM12160Stent, iliac vein1 recall1 report
- Venovo® VENUL16040Stent, iliac vein1 recall1 report
- Venovo® VENUL16060Stent, iliac vein1 recall1 report
- Venovo® VENUL16140Stent, iliac vein1 recall1 report
- Venovo® VENUL18060Stent, iliac vein1 recall1 report
- Venovo® VENUM20120Stent, iliac vein1 recall1 report
- Venovo® VENUM20160Stent, iliac vein1 recall1 report
- Venovo® VENUL20080Stent, iliac vein1 recall1 report
- Venovo® VENUL20100Stent, iliac vein1 recall1 report
- Venovo® VENUL20120Stent, iliac vein1 recall1 report
- Venovo® VENUM10040Stent, iliac vein1 recall0 reports
- Venovo® VENUM10060Stent, iliac vein1 recall0 reports
- Venovo® VENUM10080Stent, iliac vein1 recall0 reports
- Venovo® VENUM10100Stent, iliac vein1 recall0 reports
- Venovo® VENUM10120Stent, iliac vein1 recall0 reports
- Venovo® VENUM10140Stent, iliac vein1 recall0 reports
- Venovo® VENUM10160Stent, iliac vein1 recall0 reports
- Venovo® VENUL10040Stent, iliac vein1 recall0 reports
- Venovo® VENUL10060Stent, iliac vein1 recall0 reports
- Venovo® VENUL10080Stent, iliac vein1 recall0 reports
- Venovo® VENUL10100Stent, iliac vein1 recall0 reports
- Venovo® VENUL10120Stent, iliac vein1 recall0 reports
- Venovo® VENUL10140Stent, iliac vein1 recall0 reports
- Venovo® VENUL10160Stent, iliac vein1 recall0 reports
- Venovo® VENUM12040Stent, iliac vein1 recall0 reports
- Venovo® VENUL12040Stent, iliac vein1 recall0 reports
- Venovo® VENUL12060Stent, iliac vein1 recall0 reports
- Venovo® VENUL12100Stent, iliac vein1 recall0 reports
- Venovo® VENUL12120Stent, iliac vein1 recall0 reports
- Venovo® VENUL12140Stent, iliac vein1 recall0 reports
- Venovo® VENUL12160Stent, iliac vein1 recall0 reports
- Venovo® VENUM18040Stent, iliac vein1 recall0 reports
- Venovo® VENUM18060Stent, iliac vein1 recall0 reports
- Venovo® VENUL18040Stent, iliac vein1 recall0 reports
- Venovo® VENUL18080Stent, iliac vein1 recall0 reports
- Venovo® VENUL18100Stent, iliac vein1 recall0 reports
- Venovo® VENUL18160Stent, iliac vein1 recall0 reports
- Venovo® VENUM20040Stent, iliac vein1 recall0 reports
- Venovo® VENUM20060Stent, iliac vein1 recall0 reports
- Venovo® VENUL20040Stent, iliac vein1 recall0 reports
- Venovo® VENUL20140Stent, iliac vein1 recall0 reports
- Venovo® VENUL20160Stent, iliac vein1 recall0 reports
Recent Venovo adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Loss of or Failure to Bond; Positioning Failure
On (b)(6) 2026, a patient underwent a stent placement procedure using a Venovo Venous Stent in the iliac vein via femoral access. During the procedure, it was reported that the stent failed to deploy as intended. The procedure was subsequently completed using another Venovo Venous Stent. The patient was reported to be in good condition, and there was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850444 ↗MalfunctionSep 15, 2026Failure to Advance; Material Deformation
On (b)(6) 2026, A patient underwent a stent placement procedure using Venovo Stent via right femoral vein. Prior to the procedure, the stent could not be advanced over the guidewire. The procedure was completed using another device. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50767711 ↗InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT A SENT PLACEMENT PROCEDURE USING THE VENOVO STENT. DURING AN MRI SCAN, APPROXIMATELY 15 TO 20 MINUTES INTO THE PROCEDURE, THE PATIENT EXPERIENCED A HOT, BURNING SENSATION IN HER BACK AND NOTIFIED THE TECHNICIAN. THE SCAN WAS CONTINUED AT THE PATIENTS PREFERENCE, DESPITE HER REQUEST FOR A BLOOD PRESSURE CHECK, WHICH WAS NOT PERFORMED. AFTER APPROXIMATELY 40 MINUTES, SHE EXPERIENCED BACK QUIVERING ALONG WITH PERSISTENT BURNING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Burning Sensation; Shaking/Tremors; Superficial (First Degree) Burn
MAUDE report 25690349 ↗InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT A SENT PLACEMENT PROCEDURE USING THE VENOVO STENT. DURING AN MRI SCAN, APPROXIMATELY 15 TO 20 MINUTES INTO THE PROCEDURE, THE PATIENT EXPERIENCED A HOT, BURNING SENSATION IN HER BACK AND NOTIFIED THE TECHNICIAN. THE SCAN WAS CONTINUED AT THE PATIENTS PREFERENCE, DESPITE HER REQUEST FOR A BLOOD PRESSURE CHECK, WHICH WAS NOT PERFORMED. AFTER APPROXIMATELY 40 MINUTES, SHE EXPERIENCED BACK QUIVERING ALONG WITH PERSISTENT BURNING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Burning Sensation; Shaking/Tremors; Superficial (First Degree) Burn
MAUDE report 25690336 ↗MalfunctionJun 19, 2026Loss of or Failure to Bond; Positioning Failure
ON (B)(6), 2026, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING VENOVO STENT FOR ILIAC VEIN THROMBOSIS. IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25562881 ↗MalfunctionMay 15, 2026Migration or Expulsion of Device
ON A(B)(6) 2026, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING VENOVO. IT WAS REPORTED THAT AFTER DEPLOYMENT THE STENT STARTED TO MIGRATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25182561 ↗MalfunctionMar 9, 2026Activation Failure
ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING VENOVO VENOUS STENT. DURING THE PROCEDURE, THE DISTAL PORTION OF STENT DID NOT FULLY OPEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24543648 ↗MalfunctionMar 3, 2026Break; Positioning Failure; Melted
ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE VENOVO VENOUS STENT. DURING THE PROCEDURE, THE DEVICE WAS INSERTED. ONCE IT WAS TIME TO DEPLOY THE STENT, IT WAS NOTICED THAT THE UNLOCK BUTTON WAS BROKEN. FURTHERMORE, IT WAS REPORTED THAT THE BUTTON WAS UNABLE TO CLICK. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24492921 ↗MalfunctionJan 6, 2026Misfire
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING VENOVO STENT VIA RIGHT FEMORAL VEIN. DURING THE PROCEDURE, IT WAS REPORTED THAT THE LARGE WHEEL BECAME LOOSE AFTER UNLOCKING THE RED LOCK, PREVENTING FULL STENT DEPLOYMENT. THE PHYSICIAN DISASSEMBLED THE DELIVERY HANDLE AND USED THE REMAINING INTACT PIECE TO DEPLOY THE STENT; THE CATHETER WAS MANIPULATED AND PULLED TOWARD THE WIRE TO COMPLETE DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23971438 ↗MalfunctionNov 25, 2025Material Deformation; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING VENOVO VENOUS STENT DEVICE. DURING PROCEDURE, THE DEVICE ALLEGEDLY HAD MALFUNCTION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23641940 ↗InjuryOct 29, 2025Migration; Migration
A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING VENOVO VENOUS STENT. TWO DAYS LATER, ON (B)(6) 2025, IT WAS REPORTED THAT THE STENT ALLEGEDLY MIGRATED TO THE RIGHT ATRIUM AND PATIENT NEEDED TO GO TO HOSPITAL TO REMOVE THAT STENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 23413529 ↗MalfunctionOct 8, 2025Fracture; Fracture
A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE VENOVO VENOUS STENT. POST PROCEDURE, ON (B)(6) 2025 DURING AN EMBOLIZATION PROCEDURE, THEY ALLEGEDLY FOUND OUT THAT THE STRUTS ARE BROKEN OFF FROM THE VENOVO STENT WHICH WAS PLACED A YEAR AGO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23243989 ↗InjurySep 10, 2025Break; Fracture; Detachment of Device or Device Component; Break; Fracture; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT PLACEMENT OF A VENOVO STENT IN THE SUBCLAVIAN VEIN. POST PROCEDURE, THE STENT ALLEGEDLY FRACTURED AND SEPARATED INTO TWO PIECES AND THE FRAGMENTS OF STENT WERE PLACED INSIDE THE PATIENTS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 23014341 ↗MalfunctionSep 10, 2025Misfire; Misfire
ON (B)(6), 2025, A 57-YEAR-OLD MALE PATIENT UNDERGONE A STENT PLACEMENT PROCEDURE FOR MAY THURNER SYNDROME IN THE LEFT ILIAC VEIN, WITH THE ACCESS SITE OF RIGHT INTERNAL JUGULAR VEIN, USING A VENOVO STENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WAS PARTIALLY DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER DEVICE, AND THERE WERE NO REPORTED INJURIES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23013119 ↗InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT STENT PLACEMENT USING THE VENOVO STENT. POST PROCEDURE THE PATIENT ALLEGEDLY EXPERIENCED NICKEL ALLERGY. THE PATIENT STATUS IS UNKNOWN.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 22910676 ↗
Other Angiomed GmbH & Co. Medizintechnik KG products
All Angiomed GmbH & Co. Medizintechnik KG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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