VSIRecalls & reported problems across all models
Teleflex Incorporated · 31 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls
- 0
We found 31 models of VSI by Teleflex Incorporated in the FDA's device registry (GUDID). Together they are named in 61 adverse event reports in the FDA's MAUDE database, received between Oct 7, 2019 and Jul 27, 2026 — classified as 32 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Material Separation” (25 reports).
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
Most reported VSI problems
Device problems
- Material Separation25
- Detachment of Device or Device Component11
- Break7
- Separation Problem5
- Material Split, Cut or Torn4
- Fracture3
- Physical Resistance/Sticking3
- Unraveled Material2
Patient problems
- Foreign Body In Patient18
- No Clinical Signs, Symptoms or Conditions18
- Device Embedded In Tissue or Plaque9
- Insufficient Information9
- No Known Impact Or Consequence To Patient5
- Vessel Or Plaque, Device Embedded In2
- Foreign Body Embolism1
VSI models
31 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VSI IPN029488INTRODUCER, CATHETER9 reports
- VSI IPN916039INTRODUCER, CATHETER6 reports
- VSI IPN916038INTRODUCER, CATHETER6 reports
- VSI IPN029489INTRODUCER, CATHETER4 reports
- VSI IPN029498INTRODUCER, CATHETER3 reports
- VSI IPN028418INTRODUCER, CATHETER2 reports
- VSI IPN029484INTRODUCER, CATHETER2 reports
- VSI IPN029499INTRODUCER, CATHETER2 reports
- VSI IPN039061INTRODUCER, CATHETER2 reports
- VSI IPN916043INTRODUCER, CATHETER2 reports
- VSI IPN916036INTRODUCER, CATHETER2 reports
- VSI IPN916015INTRODUCER, CATHETER2 reports
- VSI IPN028412INTRODUCER, CATHETER1 report
- VSI IPN028423INTRODUCER, CATHETER1 report
- VSI IPN028428INTRODUCER, CATHETER1 report
- VSI IPN028429INTRODUCER, CATHETER1 report
- VSI IPN029482INTRODUCER, CATHETER1 report
- VSI IPN029486INTRODUCER, CATHETER1 report
- VSI IPN029487INTRODUCER, CATHETER1 report
- VSI IPN029492INTRODUCER, CATHETER1 report
- VSI IPN029495INTRODUCER, CATHETER1 report
- VSI IPN039059INTRODUCER, CATHETER1 report
- VSI IPN039073INTRODUCER, CATHETER1 report
- VSI IPN914667INTRODUCER, CATHETER1 report
- VSI IPN913184Wire, guide, catheter1 report
- VSI IPN913185Wire, guide, catheter1 report
- VSI IPN916062INTRODUCER, CATHETER1 report
- VSI IPN916048INTRODUCER, CATHETER1 report
- VSI IPN916047INTRODUCER, CATHETER1 report
- VSI IPN916034INTRODUCER, CATHETER1 report
- VSI IPN916026INTRODUCER, CATHETER1 report
Recent VSI adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50022590 ↗MalfunctionMay 11, 2026Material Separation
IT WAS REPORTED THAT "THE MICRO-INTRODUCER KIT BROKE WHILE OUR INTERVENTIONAL RADIOLOGIST WAS PLACING THE CATHETER IN THE PATIENT'S RIGHT COMMON FEMORAL ARTERY OVER A GUIDEWIRE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECE OF EQUIPMENT." GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE ISSUE AND TO ASSESS WHETHER ANY PATIENT HARM, INJURY, OR ADVERSE HEALTH CONSEQUENCES OCCURRED. A TOTAL OF THREE DOCUMENTED ATTEMPTS WERE MADE TO CONTACT THE USER FACILITY; HOWEVER, NO RESPONSE OR ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 25142942 ↗InjuryMar 23, 2026Material Separation
IT WAS REPORTED THAT: "4F MIK SHEATH SEPARATED FROM HUB UPON REMOVAL. A CUTDOWN WAS PERFORMED TO REMOVE REMAINDER OF DEVICE."
Patient problems: Foreign Body In Patient
MAUDE report 24660110 ↗InjuryMar 23, 2026Material Separation
IT WAS REPORTED THAT: "HUB FROM DILATOR/STYLET BROKE OFF DURING A PROCEDURE. MEDICAL INTERVENTION REPORTED::BROKEN PIECE WAS RETRIEVED WITH A SNARE PATIENT'S CURRENT CONDITION: FINE/STABLE NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT"
Patient problems: Foreign Body In Patient
MAUDE report 24659790 ↗MalfunctionMar 4, 2026Material Separation
IT WAS REPORTED THAT: "THE PHYSICIAN OBTAINED ACCESS TO THE RCFA WHEN HE ATTACHED THE SYRINGE TO THE MICRO SHEATH AND PULLED NEGATIVE, HE NOTICED BUBBLES. WHEN HE ATTEMPTED TO WITHDRAW THE SHEATH, IT WAS SEPARATED FROM THE HUB. HE REMOVED THE SHEATH WITHOUT INCIDENT. ANOTHER DEVICE WAS USED SUCCESSFULLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24504635 ↗MalfunctionDec 31, 2025Material Separation; Material Separation
IT WAS REPORTED THAT: "CATHETER BROKE OFF INTO PATIENT." AWAITING ADDITIONAL INFORMATION. ASSOCIATED COMPLAINTS 2134812-2025-00058 AND 2134812-2025-00059.
Patient problems: Insufficient Information
MAUDE report 23932607 ↗MalfunctionDec 31, 2025Material Separation; Material Separation
IT WAS REPORTED THAT: "CATHETER BROKE OFF INTO PATIENT." AWAITING ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 23932598 ↗InjuryApr 10, 2025Material Separation; Material Separation
IT WAS REPORTED THAT: "MICRO INTRODUCER BROKE IN HALF AND THE DISTAL PORTION WAS STUCK INSIDE THE PATIENT'S VEIN. A SNARE WAS USED TO REMOVE IT." ADDITIONAL INFORMATION: "IT WAS SUBCLAVIAN VENOUS ACCESS FOR PPM LEAD PLACEMENT. THERE WAS NO CALCIFICATION."
Patient problems: Foreign Body In Patient
MAUDE report 21812217 ↗MalfunctionFeb 19, 2025Material Separation; Material Separation
IT WAS REPORTED THAT "DR. WAS USING A MICRO PUNCTURE IN FEMORAL ACCESS CASE AND THE WIRE SNAPPED WHEN IN USE ON PATIENT". HE WAS PERFORMING A FISTULAGRAM. THE WIRE SEPARATED FROM THE FLOPPY END TO THE MANDREL. THEY WERE HAVING A HARD TIME ACCESSING INTO THE FISTULA, THEY THEN TRIED TO ACCESS FROM OPPOSITE END WITH WIRE-THEY BELIEVE THE WIRE GOT CAUGHT IN STENT STRUTS AND THEY SEPARATED. THEY TRIED SNARING THE FLOPPY END OF WIRE THAT WAS LEFT INSIDE PATIENT BUT WERE UNABLE TO RETRIEVE IT. THEY THEN USED A BIOPSY ACCESS KIT TO GET THE WIRE OUT. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH NO ISSUES, PATIENT WAS IN GOOD CONDITION. THERE WAS NO PATIENT HARM AND THEY WERE REPORTED AS FINE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21409325 ↗MalfunctionDec 9, 2024Material Separation; Material Separation
IT WAS REPORTED THAT: "THEY WERE ACCESSING THE IJ FOR A TAVR PROCEDURE. EVERYTHING WENT WELL WITH THE STICK WHEN THE WENT TO UPSIZE THE SHEATH AND PLACE THE .035 IN THE HUB. AS THEY GOT THOUGH THE HUB AND INTO THE SHEATH IT DISCONNECT THE SHEATH FROM THE HUB LEAVING THE SHEATH IN THE PATIENT. THEY HAD TO USE A SNARE TO REMOVE THE SHEATH FROM THE PATIENT."
Patient problems: Foreign Body In Patient
MAUDE report 20878549 ↗MalfunctionOct 7, 2024Material Separation; Material Separation
IT WAS REPORTED THAT " WHILE REMOVING MICROPUNCTURE TO DEPLOY ANGIOSEAL, TIP OF THE DILATOR BROKE OFF. RETRIEVED BY SNARE. CONTENTS BAGGED AND DELIVERED TO NSM.". ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER ON 25SEPT2024: "THE PATIENT DID NOT EXPERIENCE ANY NEGATIVE SYMPTOMS AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION. THE PATIENT WAS DISCHARGED SAFELY THE SAME DAY. NO EMERGENCY TREATMENT WAS NECESSARY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20382054 ↗MalfunctionSep 25, 2024
WHILE REMOVING MICROPUNCTURE DILATOR TO DEPLOY ANGIOSEAL, TIP OF DILATOR BROKE OFF. RETRIEVED BY SNARE. CONTENTS BAGGED AND DELIVERED TO NSM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20300335 ↗InjuryAug 23, 2024Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress
IT WAS REPORTED VIA MEDWATCH "WHILE GETTING ACCESS FOR PACEMAKER, MICROWIRE WRAPPED AROUND WHOLEY WIRE AND GOT KNOTTED WHILE GETTING SECOND ACCESS. WE WERE TRYING TO GET IT UNKNOTTED AND THE MICROWIRE BROKE. WE HAD TO CALL INTERVENTION RADIOLOGISTS TO RETRIEVE WIRE FROM PATIENTS LEFT SUBCLAVIAN VEIN BY SNARE FROM GROIN ACCESS". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN" AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER, NO ADDITIONAL INFORMATION HAS BEEN GIVEN AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 20047834 ↗InjuryMay 27, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT: "DURING ST-ELEVATION MYOCARDIAL INFARCTION, PATIENT WAS BROUGHT TO CATH LAB, MEDICAL DOCTOR ACCESSED LEFT GROIN, UPON GAINING ACCESS AND PUTTING IN THE 4F STIFFEN MICRO-INTRODUCER THE SHEATH BECAME DISLODGED INTO THE PATIENT'S BODY. WITH ASSISTANCE FROM VASCULAR SURGEON, THE DISLODGED SHEATH WAS RETRIEVED WITH SNARE."ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT.
Patient problems: Insufficient Information
MAUDE report 19400700 ↗InjuryMay 8, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
IT WAS REPORTED THAT: THIS PATIENT WAS IN A MITRAL CLIP PROCEDURE. A PERICARDIAL EFFUSION WAS NOTED AFTER THE MITRAL CLIPS WERE RELEASED AND PERICARDIOCENTESIS WAS PERFORMED. DURING THE PERICARDIOCENTESIS, A MICRO INTRODUCER SHEATH WAS INSERTED, AND THE PHYSICIAN HAD A DIFFICULT TIME ADVANCING THE GUIDEWIRE. AFTER ATTEMPTING TO REWIRE THE MICRO SHEATH, THE MICRO INTRODUCER SHEATH BROKE, AND THE PHYSICIAN WAS UNABLE TO RETRIEVE THE SHEATH FROM THE PATIENT'S BODY. CVTS (CARDIOVASCULAR AND THORACIC SURGERY) WAS CONTACTED, AND THE OR (OPERATING ROOM) TEAM ARRIVED TO CATH LAB TO PERFORM A SMALL PERICARDIAL WINDOW TO RETRIEVE THE SHEATH. THE RETAINED PIECE OF SHEATH WAS RETRIEVED SUCCESSFULLY, AND FRAGMENTS WERE GIVEN TO CATH LAB MANAGER.
Patient problems: Foreign Body In Patient
MAUDE report 19268124 ↗
Other Teleflex Incorporated products
- ARROW1,494 models · 9,043 reports · 62 recalls
- RUSCH220 models · 436 reports · 130 recalls
- WECK97 models · 3,790 reports · 1 recall
- HUDSON RCI152 models · 1,461 reports · 7 recalls
- LANGSTON4 models · 15 reports · 5 recalls
- PLEUR-EVAC15 models · 146 reports · 1 recall
- LMA AIRWAY MANAGEMENT47 models · 139 reports
- UROLIFT13 models · 137 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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